SYNFIX-LR SPACER

K072253 · Synthes Spine Co.Lp · OVD · Oct 12, 2007 · Orthopedic

Device Facts

• Record ID: K072253
• Device Name: SYNFIX-LR SPACER
• Applicant: Synthes Spine Co.Lp
• Product Code: OVD · Orthopedic
• Decision Date: Oct 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes SynFixTM-LR is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFixTM-LR can be packed with autograft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Device Story

Synthes SynFix-LR is a stand-alone anterior interbody fusion device; consists of a spacer component and an anteriorly-located plate. Spacer interior is packable with autograft. Four screws are inserted through the plate into adjacent vertebral bodies; screws utilize a tapered-thread locking mechanism to secure to the plate. Device is available in various heights and geometries to accommodate patient anatomy and pathology. Used by surgeons in clinical settings to facilitate spinal fusion in patients with degenerative disc disease. Provides structural support to the intervertebral space; locking mechanism ensures stability of the construct.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing.

Technological Characteristics

Combination radiolucent and radiopaque intervertebral body fusion device. Features anterior plate with four-screw tapered-thread locking mechanism. Available in multiple heights and geometries.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade I spondylolisthesis. DDD defined as discogenic back pain confirmed by history and radiography, following six months of failed non-operative treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Synthes SynFixTM-LR (K062083)
• BAK Intervertebral Body Fusion Device (P950002)

Submission Summary (Full Text)

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K072253

007 1 2 2007

| 510(k) Summary | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
| 510(k) Contact: | Susan Lewandowski<br>Manager, Spine Regulatory Affairs<br>Telephone: [phone] Facsimile: 610-719-5102<br>Email: [e-mail] |
| Date Prepared: | September 14, 2007 |
| Trade Name: | Synthes SynFixTM-LR |
| Classification: | 21 CFR 888.3080 - Intervertebral body fusion device<br>Class II (special controls)<br>Orthopaedic and Rehabilitation Devices Panel (87)<br>Product Code MAX (orthosis, spinal intervertebral fusion) |
| Predicates: | K062083 Synthes SynFixTM-LR<br>P950002 BAK Intervertebral Body Fusion Device |
| Device Description: | The Synthes SynFixTM-LR is a combination radiolucent and radiopaque<br>intervertebral body fusion device. Four screws are inserted through the<br>anteriorly-located plate into the adjacent vertebral bodies. The screws lock<br>securely to the plate using a tapered-thread locking mechanism.<br>The Synthes SynFixTM-LR is available as assembled components in<br>various heights and geometries to suit individual pathology and anatomical<br>conditions. |
| Intended Use/<br>Indications for Use: | The Synthes SynFixTM-LR is a stand-alone anterior interbody fusion<br>device indicated for use in patients with degenerative disc disease (DDD)<br>at one or two contiguous levels from L2 to S1. These DDD patients may<br>also have up to Grade I spondylolisthesis at the involved level(s). The<br>interior of the spacer component of the SynFixTM-LR can be packed with<br>autograft.<br>DDD is defined as back pain of discogenic origin with degeneration of the<br>disc confirmed by history and radiographic studies. These patients should<br>be skeletally mature and have had six months of non-operative treatment. |
| Comparison of the<br>device to predicate<br>device(s): | The Synthes SynFixTM-LR is substantially equivalent to the predicates in<br>design, function, material, and intended use. |
| Performance Date<br>(Nonclinical and/or | Non-Clinical Performance and Conclusions: |
| Clinical): | Bench testing results demonstrate that the Synthes SynFix™-LR is<br>substantially equivalent to the predicate devices. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for this device. |

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## 5 510(k) Summary – Revised 09/2007

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

Synthes Spine % Ms. Susan Lewandowski Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, PA 19380

SEP 1 2 2011

Re: K072253

Trade/Device Name: SynFix™-LR Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: September 17, 2007 Received: September 18, 2007

Dear Ms. Lewandowski:

This letter corrects our substantially equivalent letter of October 12, 2007.

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 (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 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 or any Federal statutes and regulations administered by other

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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/CDRH/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.fda.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark A. Mulkerson

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

510(k) Number (if known): K072253

Device Name: SynFix™-LR

Indications For Use:

The SynFix-LR device is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from 12 to Sl. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix-LR can be packed with autograft.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

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

Barbara Bucklin

Restorative. and Neurological Devices

510(k) Number k072253