(108 days)
No
The 510(k) summary describes a physical interbody fusion device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is an interbody fusion device for treating degenerative disc disease, which involves addressing a medical condition and restoring anatomical function.
No
The device is described as an interbody fusion device, indicated for treating degenerative disc disease by fusing vertebrae, not for diagnosing conditions. While it is used in patients diagnosed via "radiographic studies," the device itself does not perform diagnostics.
No
The device description clearly states it is a physical implantable device made of PEEK, titanium alloy, and includes screws and a plate. It is not software.
Based on the provided information, the Synthes Zero-P device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Synthes Zero-P Function: The Synthes Zero-P is a physical implantable device (an interbody fusion device) used in surgery to stabilize the cervical spine. It is not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebrae.
- Device Description: The description details the materials and components of a physical implant, not a diagnostic test kit or instrument.
Therefore, the Synthes Zero-P falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
OVE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical, C2-T1
Indicated Patient Age Range
Skeletally mature patients
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)
Synthes performed static and dynamic compression shear and torsion testing in accordance with ASTM F2077. The enclosed information demonstrates the subject device is as safe, effective and performs as well as the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Zero-P System (K072981), Synthes Zero-P [sterile screws (K093762)], Medtronic PEEK Prevail (K073285)
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.
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 Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Stacey Bonnell |
| Senior Regulatory Affairs Specialist, Synthes Spine | |
| Telephone: 610-719-5895 | |
| Facsimile: 610-719-5102 | |
| Email: 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 device |
| Class II (special controls) | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Product 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, 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. |
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 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. |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of the
technological
characteristics of
the device to the
predicate device: | 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. |
| Performance Data
(Nonclinical and/or
Clinical) | Synthes performed static and dynamic compression shear and
torsion testing in accordance with ASTM F2077. The enclosed
information demonstrates the subject device is as safe, effective
and 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 |