Backed by over thirty years of experience and expertise in the manufacturing of aneurysm clips, Aesculap now offers Yasargil aneurysm clips in two different materials: a cobalt base alloy (phynox) and a titanium alloy. Today, Aesculap offers more than
250 different aneurysm clip patterns and more than 30 different appliers.
[ add comment ] ( 16 views ) | permalink | related link |
( 3 / 157 )IsoTis OrthoBiologics, Inc.
Bone Void Filler
Resorbable calcium salt bone void filler
device.
4. Device Description
IsoTis OrthoBiologics is expanding the range of sizes previously cleared in 510(k)
K050690 to include Connexus, 0.5cc. The intended use of this additional size does not
change from that previously cleared.
Connexus is derived from selected donated human bone tissue that has been processed
into particles. The bone particles are subsequently demineralized using a hydrochloric
acid process. The demineralized bone matrix (DBM) is combined with an inert reverse
phase carrier and formulated to a putty-like consistency.
The carrier is a solution of polyethylene oxide polypropylene oxide block copolymer
dissolved in water exhibiting reverse phase characteristics (i.e., an increase in viscosity
as temperature increases).
5. Intended Use
For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability
of the bony structure. Connexus is indicated to be packed gently into bony gaps in the
skeletal system as a bone graft extender and as a bone void filler of the extremities and
pelvis. These defects may be surgically created or the result of traumatic injury to the
bone.
6. Technological Characteristics and Substantial Equivalence
Connexus and its predicate devices are similar in design, materials of construction and
function. The proposed and predicate devices are osteoconductive and osteoinductive.
The Connexus product and its predicate devices provide an interconnected, porous
scaffold and an environment for new bone ingrowth and stimulate bone growth. The only
differences between the proposed device and its predicates are the percentage of
demineralized bone and the inert carriers used. Connexus is provided sterile and for
single patient use. The donor bone in the Connexus product meets the requirements of
the AATB. Product safety and effectiveness is adequately supported by the substantial
IsoTis Special 510(k) Modification August 2005 CONFIDENTIAL
Connexus, 0.5cc Page 5
equivalence information, materials data, and test results provided in this Premarket
Notification.
Viral Inactivation Validation
The methods for processing the DBM contained in Connexus were evaluated for
their viral inactivation potential. A select panel of viruses representing various
virus types, sizes, shapes, and genomes were evaluated. The viral inactivation
testing demonstrated suitable viral inactivation potential of the processing
methods for a wide range of potential human viruses.
Osteoinductivity Potential
The osteoinductive potential of the DBM used in Connexus is determined via an
in vitro assay. The assay measures the alkaline phosphatase activity of
myoblast cells. The level of alkaline phosphatese induction is compared to
positive and negative DBM controls. Results from the assay were correlated with
results from implantation of DBM into an athymic rat muscle pouch. Analysis of
these results shows that the in vitro assay has been validated against the in vivo
athymic rat model and predicts with at least 95% confidence the in vivo
osteoinductivity of the test material. 67 out of 67 test lots that passed the in vitro
assay passed the in vivo athymic rat assay via confirmation of intramuscular
bone formation.
Each lot of DBM incorporated in the Connexus is evaluated for osteoinductive
potential using an in vitro assay. Testing each lot of DBM assures that only DBM
with ostoeinductive potential is used in Connexus. Although DBM used in the
final product has been shown to be osteoinductive using an in vitro assay, the
combination of DBM and inert carrier has not been evaluated for osteoinductivity;
therefore, it is unknown to what extent the formulation components may alter the
osteoinductivity character of the DBM. Additionally, it is unknown how
osteoinductivity of the DBM component, measured via the in vitro assay, will
correlate with human clinical performance of Connexus.
Product Performance Testing
Performance of Connexus has been evaluated in rabbit and sheep models by
radiographic and histological methods for the indications specified in the
Premarket Notification.
These data substantiate Connexus Putty safety and effectiveness for the
indications presented in this Premarket Notification.
IsoTis Special 510(k) Modification August 2005 CONFIDENTIAL
Connexus, 0.5cc Page 6
1.5 Performance Standards
No performance standards applicable to Connexus bone void filler material have been adopted
under Section 514 of the Act. Connexus complies where appropriate with the applicable
requirement of the following voluntary/consensus standards:
· ISO 10993-1: Biological Evaluation of Medical Devices Part-i: Evaluation and Testing
· 21 CFR 1270, Human Tissue Intended for Transplantation
United States Pharmacopeia (USP) XXVI - The National Formulary (NF) Specifications
XXI
United States Pharmacopeia (USP) XXVII -The National Formulary (NF) Specifications
XXII
ISO 11137:1997; Sterilization of Health Care Products - Requirements for Validation and
Routine Control - Radiation Sterilization
ASTM 1980 - 02:1999 (current edition approved Jan. 2002); Standard Guide for
Accelerated Aging of Sterile Medical Device Packages
American Association Standards for Tissue Banking, (1 0 h Edition - printing date: April
2002)
Additionally, IsoTis OrthoBiologics' Quality System complies with the FDA Quality System
Requirements (21 CFR 820), ISO 13485 and its facility is American Association of Tissue Banks
(AATB) accredited.
IsoTis Special 510(k) Modification August 2005 CONFIDENTIAL
Connexus, 0.5cc Page 7
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
SEP - 7 2005 9200Corporate Boulevard
Rockville MD 20850
Mr. Paul Doner
Director of Regulatory Affairs and Quality Assurance
lsoTis OthoBiologics Inc.
2 Goodyear, Suite B
Irvine, California 92618
Re: K052098
Trade Name: Connexus', 0.5cc
Regulation Number: 21 CFR 888.3045
Regulation Name: Resorbable calcium salt bone void filler device
Regulatory Class: 1L
Product Code: MQV
Dated: August 2, 2005
Received: August 11, 2005
Dear Mr. Doner:
We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration.
If your device is classified (see above) into either class I1 (Special Controls) or class III (PMA),
it may be subject to such additional controls. Existing major regulations affecting your device
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA
may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of[a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act's requirements, including, but not limited to: registration and listing (21
CFR Part 807): labeling (21 CFR Part 801 ); good manufacturing practice requirements as set
ibrth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2- Mr. Paul Doner
This letter will allow you to begin marketing your device as described in your Section 5 10(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your
device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled,
"Misbranding by reference to premarket notification' (21CFR Part 807.97). You may obtain
other general information on your responsibilities under the Act from the Division of Small
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or
(301) 443-6597 or at its Internet address http://wxvw.fda.gov/cdrh/industry/support/index.htmi.
Sincerely yours,
Mark Melkerson
Acting Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
1.3 Statement of Indications for Use
510(k) Number (if known):
Device Name: Connexus TM, 0.5cc
Indications for Use:
Connexus is an osteoinductive and osteoconductive bone filling material indicated:
For orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the
bony structure. Connexus is indicated to be packed gently into bony gaps in the skeletal system
as a bone graft extender and as bony void filler of the extremities and pelvis. These defects may
be surgically created or from the result of traumatic injury to the bone.
Prescription Use X AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of GenlerIl, g ,:torative,
and Neurulogical D, ces
5P˘(k) Number /40 DC)9Q O¶
IsoTis Special 510(k) Modification August 2005 CONFIDENTIAL
Connexus, 0.5cc Page 4
[ add comment ] ( 5 views ) | permalink |
( 3 / 141 )During the 2002 CSRS Meeting, Scient’x launched its Samarys Anterior Cervical Cage.
After one year, we are assessing the performance of the Samarys which is being sold worldwide.
The Samarys was created to offer immediate post-operative stability in
order to relieve pain while restoring sagittal lordosis.
The anatomical shape in conjunction with a variety of sizes, allows the cage to be perfectly adapted to the anatomy of the patient.
Additionnally, the Samarys is offered with a complete set of surgical instruments allowing for ease of use and convenience within the surgical environment.
The Samarys is recommended for a multitude of ailments including
degenerative disc disease, cervicobrachial neuralgia as a result of
disc herniation and compressive osteophytosis.
[ add comment ] ( 12 views ) | permalink | related link |
( 3 / 123 )
Calendar
