(108 days)
The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach.
The purpose of this submission is to introduce an additional, larger footprint Zero-P spacer, as well as minor modifications to approved labeling.
The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P spacer is composed of PEEK Optima (ASTM F2026-02) with a radiopaque marker (ASTM F136-2a), and a titanium alloy anterior plate and screws (ASTM F F1295-01). The screws are inserted through the plate into the adjacent vertebral bodies and lock securely to the plate using a tapered-thread locking mechanism.
The Synthes Zero-P is available as assembled components in various heights and geometries to suit individual pathology and anatomical conditions.
The provided text describes a 510(k) summary for the Synthes Zero-P "Large Footprint" intervertebral fusion device.
This document focuses on establishing substantial equivalence to predicate devices based on design and mechanical performance, rather than clinical efficacy studies with specific acceptance criteria as you might see for novel medical diagnostics or AI/ML-driven devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to a 510(k) submission for an intervertebral fusion device like the Synthes Zero-P. These types of studies are typically conducted for different types of devices, such as diagnostic imaging software or AI algorithms, where performance is measured against a ground truth and often involves human readers.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Meet or exceed the performance of predicate devices in relevant mechanical tests. | Synthes performed static and dynamic compression shear and torsion testing in accordance with ASTM F2077. The summary states, "The enclosed information demonstrates the subject device is as safe, effective and performs as well as the predicate." This implies that the device met the mechanical performance requirements to be considered substantially equivalent to the predicate devices. Specific quantitative acceptance criteria (e.g., "yield strength > X N") and the exact results are not provided in this summary but would be detailed in the full submission. |
| Material Compatibility: Use materials proven safe and effective for intervertebral fusion devices. | The Zero-P spacer is composed of PEEK Optima (ASTM F2026-02) with a radiopaque marker (ASTM F136-2a), and a titanium alloy anterior plate and screws (ASTM F F1295-01). These are commonly used biocompatible materials in spinal implants, implicitly accepted through their use in predicate devices. |
| Design and Functionality: Comparable indications, fundamental scientific technology, surgical technique, screw fixation, and design to predicate devices. | "The modifications herein presented to Synthes Zero-P device are substantially equivalent to identified predicates, Synthes Zero-P System (K072981); Synthes Zero-P [sterile screws (K093762)]; Medtronic PEEK Prevail (K073285) in indications, fundamental scientific technology, material, mechanical performance, surgical technique, screw fixation and design." |
| Indications for Use: Align with predicate device indications. | The indications for use are clearly stated and align with those for intervertebral fusion devices for degenerative disc disease. This is implicitly accepted by the FDA's clearance of the device as substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable: This device is an implantable medical device, not a diagnostic or AI/ML device that would typically have a "test set" in the sense of clinical data points for performance evaluation against a ground truth. Performance is demonstrated primarily through non-clinical (benchtop) mechanical testing and comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: See point 2. Ground truth in this context would relate to the established mechanical standards (ASTM F2077) and engineering principles for implant design. The "experts" would be the engineers and biomechanical testing professionals performing and interpreting the tests.
4. Adjudication Method for the Test Set
- Not Applicable: See point 2.
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
- Not Applicable: This is an implantable device, not an AI-driven diagnostic tool. An MRMC study is not relevant to its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is an implantable device; there is no algorithm or standalone performance study in this context.
7. The Type of Ground Truth Used
- For the non-clinical performance data, the "ground truth" is based on established engineering standards (ASTM F2077) for static and dynamic mechanical testing of intervertebral body fusion devices, and the mechanical performance characteristics of legally marketed predicate devices.
- For material composition, the ground truth is established by ASTM standards for medical-grade PEEK Optima and titanium alloy (ASTM F2026-02, ASTM F136-2a, ASTM F1295-01).
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" for this device. The design, materials, and mechanical properties are based on well-established engineering principles and existing predicate devices, not machine learning or AI models trained on data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: See point 8.
{0}------------------------------------------------
® SYNTHES®
Spine
510(K) Summary
K112459 Page 1 of 2
DEC. 1 2 2011
| Synthes Zero-P “Large Footprint“ (K112459) | |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Stacey BonnellSenior Regulatory Affairs Specialist, Synthes SpineTelephone: 610-719-5895Facsimile: 610-719-5102Email: bonnell.stacey@synthes.com |
| Date Prepared: | November 25, 2011 |
| Trade Name: | Synthes Zero-P |
| Common Name: | Intervertebral fusion device |
| Classification: | 21 CFR 888.3080 Intervertebral fusion deviceClass II (special controls)Orthopaedic and Rehabilitation Devices PanelProduct Code OVE (Intervertebral Fusion Device w/ Integrated Fixation,Cervical) |
| Predicate Devices: | Synthes Zero-P System (K072981);Synthes Zero-P [sterile screws (K093762)];Medtronic PEEK Prevail (K073285). |
| Device Description: | The purpose of this submission is to introduce an additional, largerfootprint Zero-P spacer, as well as minor modifications toapproved labeling.The Synthes Zero-P is a radiolucent and radiopaque cervicalintervertebral body fusion device. The Zero-P spacer is composedof PEEK Optima (ASTM F2026-02) with a radiopaque marker(ASTM F136-2a), and a titanium alloy anterior plate and screws(ASTM F F1295-01). The screws are inserted through the plateinto the adjacent vertebral bodies and lock securely to the plateusing a tapered-thread locking mechanism.The Synthes Zero-P is available as assembled components invarious heights and geometries to suit individual pathology andanatomical conditions. |
{1}------------------------------------------------
| . SYV(20 - 1 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -11 | |
|---|---|
| *pine |
| Intended Use /Indications for Use: | The Synthes Zero-P is a stand-alone anterior cervical interbodyfusion device indicated for use in skeletally mature patients withdegenerative disc disease (DDD) with accompanying radicularsymptoms at one level from C2-T1. DDD is defined as discogenicpain with degeneration of the disc confirmed by history andradiographic studies. These patients should have had six weeks ofnon-operative treatment. The interior of the spacer component ofthe Synthes Zero-P should be packed with autogenous bone graftand implanted via an anterior approach. |
|---|---|
| Comparison of thetechnologicalcharacteristics ofthe device to thepredicate device: | The modifications herein presented to Synthes Zero-P device aresubstantially equivalent to identified predicates, Synthes Zero-PSystem (K072981); Synthes Zero-P [sterile screws (K093762)];Medtronic PEEK Prevail (K073285) in indications, fundamentalscientific technology, material, mechanical performance, surgicaltechnique, screw fixation and design. |
| Performance Data(Nonclinical and/orClinical) | Synthes performed static and dynamic compression shear andtorsion testing in accordance with ASTM F2077. The enclosedinformation demonstrates the subject device is as safe, effectiveand performs as well as the predicate. |
.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract eagle or bird-like figure, with three curved lines representing the wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes Spine Co., L.P. % Ms. Stacey Bonnell Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
DEC 1 2 2011
Re: K112459
Trade/Device Name: Synthes Zero-P Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: November 23, 2011 Received: November 25, 2011
Dear Ms. Bonnell:
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
{3}------------------------------------------------
Page 2 - Ms. Stacey Bonnell
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/gefault.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 yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for SYNTHES Spine. The logo consists of a circular symbol with an acorn inside, followed by the word "SYNTHES" in bold, sans-serif font with a trademark symbol. Below the word "SYNTHES" is the word "Spine" in a smaller, italicized font.
Indications for Use Statement 5
| 510(k) Number:(if known) | K 112459 |
|---|---|
| Device Name: | Synthes Zero-P |
| Indications for Use: | The Synthes Zero-P is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P should be packed with autogenous bone graft and implanted via an anterior approach. |
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
and the commend of the comments of the comments of the comments of the comments of the comments of the contribution of the first of the first of the first of the first of the
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division/Sign-C | |
| Division of Surg , Orthopedic, | |
| and Restorative Devices | |
| Special 510(k) | 510(k) Number |
| K112459 | |
| Synthes Zero-P Large Footprint |
§ 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.