(245 days)
Not Found
No
The summary describes a mechanical interbody fusion device and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is indicated for degenerative disc disease (DDD) and is used in a surgical procedure to address symptoms (back pain) and degeneration of the disc, which classifies it as a therapeutic device.
No
The device is an interbody fusion device, specifically a stand-alone lateral lumbar interbody fusion device, used for surgical treatment of degenerative disc disease. Its purpose is to provide stability and promote fusion between vertebrae, not to diagnose medical conditions.
No
The device description clearly states it is a "combination radiolucent and radiopaque intervertebral body fusion device" with "four screws" and a "laterally located plate," indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a surgical procedure (lumbar interbody fusion) using a physical implant to treat a medical condition (degenerative disc disease). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (spacer, plate, screws) designed to be surgically inserted into the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect substances, or provide information about a patient's health status through in vitro testing.
The device is a surgical implant used for treatment, not for diagnosis.
N/A
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.
Product codes
OVD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to L5 (lumbar spine)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072253, P950002 S014, K121982, K103382, K123180
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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. | |
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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
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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