(30 days)
Not Found
No
The device description focuses on the materials and mechanical components of the interbody fusion device and does not mention any software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is an interbody fusion device for patients with degenerative disc disease, which aims to treat a medical condition.
No
This device is described as an "anterior cervical interbody fusion device" and an "intervertebral body fusion device" used for skeletal fusion. Its function is to provide stabilization and promote fusion, not to diagnose medical conditions.
No
The device description clearly details physical components made of PEEK, titanium alloy, and Elgiloy, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for an anterior cervical interbody fusion device used in surgery to treat degenerative disc disease. This is a surgical implant, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical implant made of PEEK and titanium, designed to be surgically placed in the spine. It includes components like a spacer, plate, and screws.
- Lack of Diagnostic Function: The device's function is to provide structural support and facilitate bone fusion, not to diagnose a condition by analyzing biological samples. The radiopaque marker is for intra-operative positioning, not diagnostic analysis.
- No Mention of Biological Samples: There is no mention of the device interacting with or analyzing blood, urine, tissue, or any other biological sample.
- Focus on Surgical Implantation: The description and intended use clearly point to a device used in a surgical procedure.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
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 and are currently offered non-sterile. This line extension covers the addition of sterile-packed screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
Anatomical Site
Cervical spine, one level from 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)
Non-Clinical Performance and Conclusions:
Non-clinical performance data and conclusions were not needed for this device.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
ア
[
","s"
-
510(k) Summary
| 510(k) Summary | ||
|---|---|---|
| Name of Firm: | Synthes Spine | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| 510(k) Contact: | Monika McDole-Russell | |
| Regulatory Affairs Specialist, Synthes Spine | ||
| Telephone: 610-719-5448 | ||
| Facsimile: 610-719-5102 | ||
| Email: mcdole-russell.monika@synthes.com | ||
| Date Prepared: | June 22, 2012 | |
| 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 with Integrated | ||
| Fixation, Cervical) | ||
| Predicates: | Synthes Zero-P device (K093762, K112459) | |
| Synthes Zero-P VA device (K112068) | ||
| 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 and are currently offered non-sterile. This line extension | ||
| covers the addition of sterile-packed screws. | ||
| 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. | ||
| Comparison of the | ||
| device to predicate | ||
| device(s): | The modifications herein presented to the Synthes Zero-P VA | |
| device are substantially equivalent to the above referenced | ||
| predicates in design, function, and intended use. | ||
| Performance Date | ||
| (Nonclinical and/or | ||
| Clinical): | Non-Clinical Performance and Conclusions: | |
| Non-clinical performance data and conclusions were not needed for | ||
| this device. | ||
| Clinical Performance and Conclusions | ||
| Clinical data and conclusions were not needed for this device. |
Synthes Zero-P VA – Sterile-Packed Screws Special 510(k)
. ·
sheet 1 of 2
1
SYNTHES®
. . . .
i
i
Spine
the control control control controlled
Synthes Zero-P VA – Sterile-Packed Screws Special 510(k) .
:
sheet 2 of 2
・
.
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized abstract design resembling an eagle or bird in flight, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the left side of the emblem. The design is simple, using only black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Synthes Spine % Ms. Monika McDole-Russell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
JUL 25 2012
Re: K121852
Trade/Device Name: Synthes Zero-P VA Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: June 22, 2012 Received: June 25, 2012
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2- Ms. Monika McDole-Russell
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 A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device 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 a stylized figure inside, followed by the word "SYNTHES" in bold, sans-serif font with a trademark symbol. Below "SYNTHES" is the word "Spine" in a smaller, italicized font.
Spine
10. Indications for Use Statement
510(k) Number: (if known)
K 121852
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 ievel 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 × (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
sheet 1 of 1
K121852 510(k) Number_
Synthes Zero-P VA - Sterile Screws Special 510(k)