← Product Code [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD) · K131276 # LATERAL SYNFIX (K131276) _Synthes (USA) Products, LLC · OVD · Jan 6, 2014 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K131276 ## Device Facts - **Applicant:** Synthes (USA) Products, LLC - **Product Code:** [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD.md) - **Decision Date:** Jan 6, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The SYNFIX Lateral is a stand-alone lateral lumbar interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. The interior of the SYNFIX Lateral spacer component should be packed with autogenous bone graft (i.e. autograft); all four screws must be used when implanting this device. 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 Stand-alone lateral lumbar interbody fusion device; consists of radiolucent/radiopaque spacer and four screws. Screws lock to plate via conical thread mechanism. Implanted by surgeons in clinical setting. Spacer interior packed with autogenous bone graft; all four screws required for implantation. Provides stabilization for spinal fusion. Benefits patient by addressing discogenic pain through structural support and fusion facilitation. ## Clinical Evidence No clinical data. Bench testing performed per ASTM F2077-11 and ASTM F2267-04 (static/dynamic axial compression, static/dynamic compression shear, expulsion, subsidence). Cadaveric studies evaluated flexion/extension and lateral bending. MR safety/compatibility established per ASTM F2052, F2213, F2182, and F2119. ## Technological Characteristics Intervertebral body fusion device; combination radiolucent and radiopaque materials. Features integrated fixation via four screws with conical thread locking mechanism. Tested per ASTM F2077-11, F2267-04, F2052, F2213, F2182, and F2119. No software or electronic components. ## Regulatory 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 SynFix-LR Spacer ([K072253](/device/K072253.md)) - Zimmer Spine BAK Vista Interbody Fusion Cage ([P950002](/device/P950002.md) S014) - Medtronic SOVEREIGN ([K121982](/device/K121982.md)) - Globus Medical InterContinental ([K103382](/device/K103382.md)) - DePuy Synthes Falcon Spacer ([K123180](/device/K123180.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K131276 Page 1 of 2 : ## 510(k) Summary | 510(k) Summary -SYNFIX Lateral | | | |--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Name of Firm: | DePuy Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 | | | 510(k)
Contact: | Monika McDole-Russell
Regulatory Affairs Specialist
Telephone: 610-719-5448
Facsimile: 484-356-9682
Email: mcdole-russell.monika@synthes.com | | | Date Prepared: | January 3, 2014 | | | Trade
Name(s): | DePuy Synthes SYNFIX Lateral | | | Classification: | 21 CFR 888.3080 - Intervertebral Body Fusion Device
Class II (special controls)
Orthopaedic and Rehabilitation Devices Panel (87)
Product Code OVD (Intervertebral Fusion Device with Integrated
Fixation, Lumbar) | | | Predicates: | Synthes SynFix-LR Spacer (K072253)
Zimmer Spine BAK Vista Interbody Fusion Cage (P950002 S014)
Medtronic SOVEREIGN (K121982)
Globus Medical InterContinental (K103382)
DePuy Synthes Falcon Spacer (K123180) | | | Device
Description(s): | The DePuy Synthes SYNFIX Lateral is a combination radiolucent and
radiopaque intervertebral body fusion device. Four screws are inserted
through the laterally located plate into the adjacent vertebral bodies. The
screws lock securely to the plate using a conical thread locking
mechanism.
The DePuy Synthes SYNFIX Lateral is available in various heights and
geometries to suit individual pathology and anatomical conditions. | | | Intended Use/
Indications for
Use: | The SYNFIX Lateral is a stand-alone lateral lumbar interbody fusion
device indicated for use in patients with degenerative disc disease (DDD)
at one or two contiguous levels from L2 to L5. The interior of the
SYNFIX Lateral spacer component should be packed with autogenous
bone graft (i.e. autograft); all four screws must be used when implanting
this device.
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. | | | 510(k) Summary –SYNFIX Lateral | | | | Comparison of
the device to
predicate
device(s): | The DePuy Synthes SYNFIX Lateral Spacer is substantially equivalent to
the predicates in design, function, performance, material, and intended
use. | | | Performance
Data
(Non-Clinical
and/or
Clinical): | Non-Clinical Performance and Conclusions:
DePuy Synthes conducted the following bench testing (as recommended
within FDA Guidances and in accordance with ASTM F2077-11 and
ASTM F2267-04): Static Axial Compression; Dynamic Axial
Compression; Static Compression Shear; Dynamic Compression Shear;
Expulsion; Subsidence. Cadaveric studies were conducted to evaluate
performance in flexion/extension and lateral bending.

The conclusions drawn from testing demonstrate that the DePuy Synthes
SYNFIX Lateral is substantially equivalent in performance to predicate
devices.

In addition, the safety and compatibility of SYNFIX Lateral implants in
an MR environment was established (as recommended with FDA
Guidance and in accordance with the ASTM F2052, ASTM F2213,
ASTM F2182 and ASTM F2119).

Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device. | | {1}------------------------------------------------ : . : : : . . . . : : {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters and is evenly spaced around the circle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 6, 2014 Depuy Synthes Spine Ms. Monika McDole-Russell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380 Re: K131276 Trade/Device Name: DePuy Synthes SYNFIX Lateral Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: November 26. 2013 Received: November 27, 2013 Dear Ms. McDole-Russell: 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 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 {3}------------------------------------------------ #### Page 2 - Ms. Monika McDole-Russell 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. # Lori A. Wiggins - for Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K131276 Page 1 of 1 ### Indications for Use Statement K_ 131276 510(k) Number(s): (if known) Device Name: DePuy Synthes SYNFIX Lateral The SYNFIX Lateral is a stand-alone lateral lumbar interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. The interior of the SYNFIX Lateral spacer component should be packed with autogenous bone graft (i.e. autograft); all four screws must be used when implanting this device. 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. > Anton EDmitriev, PhD Division of Orthopedio Devices --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K131276](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K131276) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com