(110 days)
No
The device description focuses on the materials and mechanical components of the interbody fusion device. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The performance studies are bench tests evaluating mechanical properties, not algorithmic performance.
Yes
The device is indicated for use in treating degenerative disc disease, which is a medical condition. It is designed to provide interbody fusion, alleviating symptoms and restoring function, thereby fitting the definition of a therapeutic device.
No
Explanation: The Synthes Zero-P VA is described as an "anterior cervical interbody fusion device" and an "intervertebral body fusion device." Its purpose is to facilitate spinal fusion in patients with degenerative disc disease, not to diagnose medical conditions. It is an implantable therapeutic device, not a diagnostic one.
No
The device description clearly details physical components made of PEEK, titanium alloy, and Elgiloy, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus.
- Device Description: The Synthes Zero-P VA is an implantable surgical device used for spinal fusion. It is a physical object inserted into the body to provide structural support and promote bone growth.
- Intended Use: The intended use is to facilitate anterior cervical interbody fusion in patients with degenerative disc disease. This is a therapeutic procedure, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant, not a device used for testing biological samples in a lab setting.
N/A
Intended Use / Indications for Use
The Synthes Zero-P VA 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 VA should be packed with autogenous bone graft and implanted via an anterior approach.
Product codes
OVE
Device Description
The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion device. The Synthes Zero-P VA is composed of a spacer made from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows accurate intra-operative radiographic assessment of the position of the implant. The spacer component is preassembled with a mating titanium alloy (Ti-6Al-7Nb; TAN; ASTM F1295) interbody plate. The device is implanted anteriorly by inserting two screws (TAN) through the plate, one screw per vertebral body. The interbody plate incorporates a lock-catch mechanism in each screw hole comprised of a TAV lock-screw and catch, as well as an Elgiloy (ASTM F1058) spring. The screws offered with the Zero-P VA system are 3.7mm in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1 (cervical spine)
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)
Non-Clinical Performance and Conclusions:
Synthes conducted the following bench testing (as recommended within FDA Guidance and in accordance with ASTM F2077-03 and ASTM F2267-04): Static Axial Compression; Dynamic Axial Compression; Static Compression Shear; Dynamic Compression Shear; Static Torsion; Dynamic Torsion; and Subsidence. The conclusions drawn from testing demonstrate that the Synthes Zero-P VA device is substantially equivalent in performance to the following predicate devices: Synthes Zero-P device (K072981); Sulzer BAK™/Cervical IBF (P980048); and Medtronic PEEK Prevail (K073285).
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)
Synthes Zero-P device (K072981), Sulzer BAK™/Cervical IBF (P980048), Synthes Vectra (K050451), Synthes Vectra-T (K051665), Globus Coalition (K083389), Medtronic PEEK Prevail (K073285), RSB InterPlate C-P (K092070)
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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® SYNTHES® Spine
Page 1 of 2
| Synthes Zero-P VA (K112068)
| 510(k) Summary | |
|---|---|
| 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 7, 2011 |
| Trade Name: | Synthes Zero-P VA |
| Classification: | 21 CFR 888.3080 - Intervertebral Body Fusion Device |
| Class II (special controls) | |
| Orthopaedic and Rehabilitation Devices Panel (87) | |
| Product Code OVE (Intervertebral Fusion Device w/ Integrated Fixation, | |
| Cervical) | |
| Predicates: | Synthes Zero-P device (K072981); |
| Sulzer BAK™/Cervical IBF (P980048); | |
| Synthes Vectra (K050451); | |
| Synthes Vectra-T (K051665); | |
| Globus Coalition (K083389) | |
| Medtronic PEEK Prevail (K073285) | |
| RSB InterPlate C-P (K092070) | |
| Device Description: | The Synthes Zero-P VA is a radiolucent and radiopaque |
| intervertebral body fusion device. The Synthes Zero-P VA is | |
| composed of a spacer made from Invibio® PEEK-Optima® LT-1 | |
| (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V | |
| ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows | |
| accurate intra-operative radiographic assessment of the position of | |
| the implant. The spacer component is preassembled with a mating | |
| titanium alloy (Ti-6Al-7Nb; TAN; ASTM F1295) interbody plate. | |
| The device is implanted anteriorly by inserting two screws (TAN) | |
| through the plate, one screw per vertebral body. The interbody plate | |
| incorporates a lock-catch mechanism in each screw hole comprised | |
| of a TAV lock-screw and catch, as well as an Elgiloy (ASTM | |
| F1058) spring. The screws offered with the Zero-P VA system are | |
| 3.7mm in diameter. | |
| Intended Use/ | The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion |
1
.
:
| SYNTHES® |
|---|
| Spine |
| Indications for Use: | 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 VA should be packed with autogenous
bone graft and implanted via an anterior approach. |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of the
device to predicate
device(s): | The Synthes Zero-P VA is substantially equivalent to the established
predicates in design, function, material and intended use. |
| Performance Date
(Nonclinical and/or
Clinical): | Non-Clinical Performance and Conclusions:
Synthes conducted the following bench testing (as recommended within
FDA Guidance and in accordance with ASTM F2077-03 and ASTM
F2267-04): Static Axial Compression; Dynamic Axial Compression; Static
Compression Shear; Dynamic Compression Shear; Static Torsion;
Dynamic Torsion; and Subsidence. The conclusions drawn from testing
demonstrate that the Synthes Zero-P VA device is substantially equivalent
in performance to the following predicate devices: Synthes Zero-P device
(K072981); Sulzer BAK™/Cervical IBF (P980048); and Medtronic PEEK
Prevail (K073285).
Clinical Performance and Conclusions
Clinical data and conclusions were not needed for this device. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 7 2011
Synthes Spine Co., L.P. % Ms. Stacey Bonnell Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K112068
Trade/Device Name: Synthes Zero-P Variable Angle (VA) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 04, 2011 Received: October 05, 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
3
Page 2 - Ms. Stacey Bonnell
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 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 (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
@ SYNTHES® Spine
4 Indications for Use Statement
510(k) Number: K112068 (if known)
Device Name: Synthes Zero-P VA
Indications for Use: The Synthes Zero-P VA 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 VA 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)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
KITZO68 510(k) Number.