ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.

Device Description

ORTHOVITA PEEK SPACER is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an aid in spinal fixation. Machined from medical grade PEEK-OPTIMA®, the device is trapezoidal in shape with a hollow frame to accept autogenous bone graft. ORTHOVITA PEEK SPACER is available in a range of heights and geometries to accommodate individual pathologies and anatomical conditions.

AI/ML Overview

This document describes an intervertebral body fusion device and its pre-clinical testing, not a study evaluating a device's performance against specific acceptance criteria for diagnostic output. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be found in the provided text.

Here is the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Static and dynamic axial compression (ASTM F2077)	Not explicitly stated, but implied to be compliant with ASTM F2077	"The acceptance criteria of all tests were met." (for all listed tests)
Static and dynamic torsion (ASTM F2077)	Not explicitly stated, but implied to be compliant with ASTM F2077	"The acceptance criteria of all tests were met." (for all listed tests)
Static subsidence testing (ASTM F2267)	Not explicitly stated, but implied to be compliant with ASTM F2267	"The acceptance criteria of all tests were met." (for all listed tests)

Note: The document states that the acceptance criteria for all tests were met, but it does not quantitatively define what those criteria were. It refers to the ASTM standards but doesn't detail the specific pass/fail thresholds used.

2. Sample size used for the test set and the data provenance

The provided text describes pre-clinical bench testing, not a clinical study involving a test set of data. Therefore, this information is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not a diagnostic or AI-driven device requiring expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not a diagnostic or AI-driven device requiring ground truth adjudication.

5. 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

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not a diagnostic or AI-driven device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable. For this device, "ground truth" would be the engineering specifications and performance limits defined by the ASTM standards and the device's design, which were verified through physical testing.

8. The sample size for the training set

This information is not applicable as the document describes pre-clinical bench testing, not a machine learning study.

9. How the ground truth for the training set was established

This information is not applicable as the document describes pre-clinical bench testing, not a machine learning study.

Summary

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510(k) SUMMARY ORTHOVITA PEEK SPACER

November 19, 2010

JAN 2 5 2011

510(k) Number (if known): K101171

1. Contact Person

Catherine Moffa, M.S. Director, Regulatory Affairs (e-mail) cmoffa@orthovita.com

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 (t) 610-640-1775 - (f) 610-640-1714

2. Device Name and Classification

Product Name:	ORTHOVITA PEEK SPACER
Classification Name:	Intervertebral body fusion device with bone graft, cervical
Common or Usual Name:	Intervertebral body fusion device
Classification Panel:	Orthopedic
Regulation Number:	888.3080
Device Class:	Class II
Product Code:	ODP

3. Predicate Device(s)

Choice Spine's Cervical Interbody Spacer and System (K091531)

4. Device Description

5. Indications for Use

ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.

6. Performance Data

The below list of preclinical bench testing was performed on the ORTHOVITA PEEK SPACER. The acceptance criteria of all tests were met.

Static and dynamic axial compression, and static and dynamic torsion in accordance with ASTM F2077, 트 Test Methods for Intervertebral Body Fusion Devices
Static subsidence testing in accordance with ASTM F2267, Standard Test Method for Measuring Load I Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression

7. Substantial Equivalence

Information within this submission supports substantial equivalence.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Orthovita, Inc. % Ms. Catherine Moffa, M.S. Director, Regulatory Affairs 45 Great Valley Parkway Malvern, Pennsylvania 19355

JAN 2 5 201

Re: K101171

Trade/Device Name: Orthovita Peek Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 20, 2010 Received: January 21, 2011

Dear Ms. Moffa:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 – Ms. Catherine Moffa, M.S.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.lda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

y yours,

Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K101171

Device Name: ORTHOVITA PEEK SPACER

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off (Division Sign-On)
Division of Surgic: ) Orthopedic,
Division of Surgic: Douices Division of Surgers -

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510(k) Number .

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.