(90 days)
ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ALLOMATRIX® Putty is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose.
ALLOMATRIX® Putty comes in the form of a kit with a premeasured powder, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.
This submission discusses the ALLOMATRIX® Putty, a bone void filler. The provided text, however, does not contain information about acceptance criteria, a study proving device performance against those criteria, or the details of such a study as requested in your prompt.
The document primarily focuses on:
- Device Description and Intended Use: Explaining what the ALLOMATRIX® Putty is and where it's used (bony voids or gaps in extremities and pelvis).
- Substantial Equivalence: Stating that the device is substantially equivalent to a predicate device.
- Osteoinductivity Potential: Describing how the osteoinductivity potential of the demineralized bone matrix (DBM) component is assessed in vitro using an immunoassay as a surrogate marker and correlated with an athymic rat model. It explicitly states that it is unknown how this surrogate immunoassay will correlate with human clinical performance.
- Regulatory Clearance: The FDA's letter granting 510(k) clearance based on substantial equivalence.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or clinical performance metrics for this device based on the provided text. The document indicates that safety and effectiveness are supported by "substantial equivalence information and testing results provided within this Premarket Notification," but these specific results and criteria are not detailed in the given extract.
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AUG - 2 2004 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of ALLOMATRIX® Putty.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | May 3, 2004 |
| Contact Person: | Roger D. BrownSr. Director, Clinical, Regulatory & Reimbursement |
| Proprietary Name: | ALLOMATRIX® Putty |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Filler, Calcium Sulfate Preformed Pellets - Class II,888.3045 |
| Device Product Code and Panel Code: | Orthopedics/MOV |
DEVICE INFORMATION
A. INTENDED USE
ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
B. DEVICE DESCRIPTION
ALLOMATRIX® Putty is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose.
ALLOMATRIX® Putty comes in the form of a kit with a premeasured powder, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.
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SUBSTANTIAL EQUIVALENCE INFORMATION ﻥ
ALLOMATRIX® Putty was found to be substantially equivalent to the predicate device. The safety and effectiveness of ALLOMATRIX® Putty is adequately supported by the substantial equivalence information and testing results provided within this Premarket Notification.
Osteoinductivity Potential
Each lot of DBM incorporated into ALLOMATRIX® Putty is assayed in vitro for a native protein as a surrogate test marker for osteoinductive potential.1 Results from this immunoassay were correlated to the athymic rat model for the DBM alone and the ALLOMATRIX Putty. - Testing each lot of DBM with this immunoassay assures that only DBM with osteoinductivity potential is used in the ALLOMATRIX® Putty. Additionally, the DBM native protein in vitro assay correlation with the ALLOMATRIX® Putty predicts the osteoinductive potential of the ALLOMATRIX® Putty in the athymic rat model. Although only one native protein is used as the test marker, it is the combination of various proteins in the DBM that is responsible for its osteoinductivity potential. Additionally, it is unknown how osteoinductivity potential, measured by this surrogate immunoassay, will correlate with human clinical performance of the Allomatrix Putty.
- Data on file at Wright Medical Technology, Inc. ]
- 2 Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in compositive grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug;(150):288-300.
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Image /page/2/Picture/1 description: The image is a black and white emblem. The emblem features a stylized bird in flight, composed of three curved lines. The bird is oriented to the right. Encircling the bird is text that reads "HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 2004
Mr. Roger D. Brown Director, Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002
Re: K041168
ALLOMATRIX® Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: May 3, 2004 Received: May 4, 2004
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed yoursed your entermined the device is substantially equivalent (for the referenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to activelic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls providents on 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 II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), it may of bund 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 mean that + Dr may Federal statutes and regulations administered by other Federal agencies. or the Act of any - outh all the Act's requirements, including, but not limited to: registration 1 ou intist compty with 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (2) - et read in the quality systems (QS) regulation (21 CFR Part 820); and if
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Page 2 – Mr. Roger D. Brown
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This retter will and in you 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), r you desire specific across of Compliance at (301) 594-4659. 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 may obtain 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://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milburn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(K) Number (if known):_KO4 | | 86
Device Name: ALLOMATRIX® Putty
Indications for Use:
ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the ALLOMATICA - Tate I ater is marcated o be gently is intended to be gently packed into bony stablity of the skeletal system (i.e., the extremities and pelvis). These defects may be vords of Eaps of the excessed of osseous defects created from traumatic injury to the bone.
Prescription Use _ X (Per21 CFR 801.109) OR
Over-The Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mule N. Millican
Division of General, Restorative, and Neurological Devices
510(k) Number.
Page 1 of 1
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.