OSTEOMIMETIC SYNTHETIC BONE MATRIX by BIOMIMETIC PHARMACEUTICALS INC.

OsteoMimetic™ Synthetic Bone Matrix is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. The OsteoMimetic matrix is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone in conjunction with standard measures.

Device Description

OsteoMimetic Synthetic Bone Matrix is a synthetic, multicrystalline, porous form of ß-tricalcium phosphate [Cas(PO4)2]. The matrix physically fills bone defects to prevent the collapse of soft tissue and stabilize the blood clot. It provides a biocompatible, osteoconductive, and three-dimensional scaffold to facilitate new bone formation. As the matrix is resorbed, bone and other connective tissues grow into the space previously occupied by the matrix. OsteoMimetic Synthetic Bone Matrix is provided sterile as 1-2mm particles.

AI/ML Overview

Here's an analysis of the provided text regarding the OsteoMimetic™ Synthetic Bone Matrix, focusing on acceptance criteria and study details.

Based on the provided K051775 document, there is no specific performance acceptance criteria or a dedicated study described to "prove the device meets acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. This document is a 510(k) Premarket Notification, which typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than presenting new clinical efficacy data against defined performance thresholds.

The safety and effectiveness information in this document primarily relies on:

Compliance with an ASTM standard for composition: ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for Surgical Implantation."
Biocompatibility testing: According to ISO 10993.
Prior safe use of predicate devices.

Therefore, most of the requested fields related to a clinical study establishing performance criteria cannot be answered from this document.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Composition: Conforms to ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for Surgical Implantation."	Tested to conform to ASTM F1088. (Specific compositional analysis details are not provided in this summary).
Biocompatibility: Established based on ISO 10993 biocompatibility testing.	Biocompatibility was established based on ISO 10993 testing. (Specific test results are not provided in this summary).
Safety and Effectiveness (Substantial Equivalence): Demonstrated to be substantially equivalent to predicate devices (Depuy Conduit™ TCP Granules, K014053; Synthes chronOS, K013072; OrthoVita VitOss™ Scaffold Synthetic Cancellous Bone Void Filler, K994337) which have been used safely for many years in the clinical environment.	The FDA reviewed the 510(k) and determined the device is substantially equivalent to the referenced predicate devices.

Study Information (Based on Available Data)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The document does not describe a clinical trial or performance study with a "test set" in the context of diagnostic accuracy or clinical efficacy. The substantial equivalence relies on existing data/knowledge of predicate devices and material standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. No such ground truth establishment is described for a test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device (a bone void filler) is not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to its predicate device submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Indirectly, safety and performance are inferred from conformance to material standards (ASTM F1088, ISO 10993) and the established history of predicate devices. There is no direct "ground truth" for clinical outcomes presented for this specific device in this document, as the submission focuses on substantial equivalence for a material.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this 510(k) submission.
How the ground truth for the training set was established:
- Not applicable. There is no "training set" or associated ground truth establishment described.

Summary

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K051775

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION 3. BioMimetic Pharmaceuticals, Inc. SPONSOR: 389A Nichol Mill Lane Franklin, TN 37067 Sandra Williamson Contact: Manager, Regulatory Affairs OsteoMimetic™ Synthetic Bone Matrix (OsteoMimetic DEVICE TRADENAME: matrix) Resorbable calcium salt bone void filler device COMMON OR USUAL NAME: Class II: 21 CFR 888.3045 (ProCode MQV) CLASSIFICATION: Depuy Conduit™ TCP Granules, K014053 PREDICATE DEVICE: Synthes chronOS, K013072 OrthoVita VitOss™ Scaffold Synthetic Cancellous Bone Void Filler, K994337 DEVICE DESCRIPTION: OsteoMimetic Synthetic Bone Matrix is a synthetic, multicrystalline, porous form of ß-tricalcium phosphate [Cas(PO4)2]. The matrix physically fills bone defects to prevent the collapse of soft tissue and stabilize the blood clot. It provides a biocompatible, osteoconductive, and three-dimensional scaffold to facilitate new bone formation. As the matrix is resorbed, bone and other connective tissues grow into the space previously occupied by the matrix. OsteoMimetic Synthetic Bone Matrix is provided sterile as 1-2mm particles. SAFETY: OsteoMimetic matrix is tested to conform to ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for Surgical Implantation." Biocompatibility was established based on ISO 10993 biocompatibility testing. The predicate devices to which substantial equivalence is claimed have been used safely for many years in the clinical environment. INTENDED USE: OsteoMimetic matrix is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. The OsteoMimetic matrix is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone in conjunction with standard measures.

BioMimetic Pharmaceuticals, Inc. Confidential

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2005

Ms. Sandra Williamson Manager, Regulatory Affairs BioMimetic Pharmaceuticals, Inc. 389-A Nichol Mill Lane Franklin, Tennessee 37067

Re: K051775

K051775
Trade/Device Name: OsteoMimetic™ Synthetic Bone Matrix Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: July 1, 2005 Received: July 1, 2005

Dear Ms. Williamson:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 3 IQC ) premaited is substantially equivalent (for the indications
referenced above and have determined the device marketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predices marketed in interstate for use stated in the enclosure) to regally manced to declacal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue commerce prior to May 28, 1976, the enactinent with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance was are wares approval application (PMA).
and Cosmetic Act (Act) that do not require approval control control control on oth and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general controls provisi You may, therefore, market the device, subject to the general registration, listing of
general controls provisions of the Act include requirements mishranding and general controls provisions of the Act include requirements and more of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nito entire) and in the major regulations affecting your device can
may be subject to such additional controls. Existing major regul may be subject to such additional controls: Listing major regalitations of the may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In addition, FDA be found in the Code of Pederal Regarations, Friday, Friday, An the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Active in the start the complies with other requirements of the Act Please be advised that FDA s issualited of a substantity of the requirements of the Act
that FDA has made a determination that your device as agencies. You must that FDA has made a determilation that your devices by other Federal agencies. You must
or any Federal statutes and regulations administered by other registration and listi or any Federal statutes and regulations and limited to: registration and listing (21
comply with all the Act's requirements, including, but not bearing provinements as set comply with all the Act s requirements, including, out many of the requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as CFR Part 807); labeling (21 CFR Patl on (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050, forth in the quality systems (QS) regulation (27 CFR Parts of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050

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Page 2 – Ms. Sandra Williamson

This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and the more to may of aliance for betweenes of your device to a legall This letter will allow you to begin maketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of you premarket notification. The PDA Inding of substantial equivalians 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
r of the results of the results of A100 - Alas, places note the regulation If you desire specific advice for your device on on on accessar not the regulation entitled,
contact the Office of Compliance at (240) 276-0120 . Also, please not of . . You contact the Office of Complialice at (240) 270 - 1200 P Pat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to premarkst nonifedron (1978) 4 of from the Division of Small
other general information on your responsibilities under the Act from number (800) 63 other general information on your responsion its toll-free mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (800) by the Manufacturers, International and Consumer Assistance a no vol. 2012-01-2011
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Acting 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

K051775 510(k) Number (if known):

OsteoMimetic™ Synthetic Bone Matrix Device Name:

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510K * K051775
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

Page 1 of 1

510(k) Number K051775

Regulation Number and Section

§ 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.