(111 days)
Not Found
No
The 510(k) summary describes a mechanical interbody fusion device and does not mention any AI or ML components or functionalities.
Yes
The device is used to treat degenerative disc disease, which is a medical condition. Its function is to facilitate interbody spinal fusion, aiming to alleviate pain and symptoms.
No
This device is a stand-alone anterior cervical interbody fusion device, designed to provide stability and support in the spine after disc removal, rather than to diagnose medical conditions.
No
The device description explicitly states it is composed of physical components: a PEEK spacer, a titanium alloy anterior plate, and screws. This indicates it is a hardware medical device, not software-only.
Based on the provided information, the Synthes Zero-P is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to provide structural support and facilitate bone growth.
- Device Description: The description details a physical implant made of PEEK and titanium, designed to be surgically inserted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide diagnostic information. IVDs are typically used in laboratories or point-of-care settings for testing and analysis.
Therefore, the Synthes Zero-P falls under the category of a surgical implant or medical device, not an IVD.
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
ODP, OVE
Device Description
The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral body fusion device. The Zero-P is composed of a PEEK spacer with a radiopaque marker, a titanium alloy anterior plate and screws. The screws are inserted through the plate into the adjacent vertebral bodies. The screws 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
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)
Bench testing results demonstrate that the Synthes Zero-P is substantially equivalent to the predicate devices.
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P980048, P000028, K072253, K011037
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
Ko72981
r == 11 == =
510(k) Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine |
| 1302 Wrights Lane East | |
| West Chester, PA 19380 | |
| 510(k) Contact: | Susan Lewandowski |
| Manager, Spine Regulatory Affairs | |
| Telephone: 610-719-5712 | |
| Facsimile: 610-719-5102 | |
| Email: lewandowski.susan@synthes.com | |
| Date Prepared: | January 15, 2008 |
| Trade Name: | Synthes Zero-P |
| Classification: | 21 CFR 888.3080 - Intervertebral fusion device |
| Class II (special controls) | |
| Orthopaedic and Rehabilitation Devices Panel (87) | |
| Product Code ODP (Intervertebral Fusion Device with Bone Graft, | |
| Cervical) | |
| Predicates: | P980048 BAK/Cervical Interbody Fusion Device (Sulzer Spine-Tech) |
| P000028 Affinity Anterior Cervical Cage System (Medtronic Vascular) | |
| K072253 SynFix-LR (Synthes Spine) | |
| K011037 Vertebral Spacer (Synthes Spine) | |
| Device Description: | The Synthes Zero-P is a radiolucent and radiopaque cervical intervertebral |
| body fusion device. The Zero-P is composed of a PEEK spacer with a | |
| radiopaque marker, a titanium alloy anterior plate and screws. The screws | |
| are inserted through the plate into the adjacent vertebral bodies. The | |
| screws 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. | |
| 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 | |
| device to predicate | |
| device(s): | The Synthes Zero-P is substantially equivalent to the predicates in design, |
| function, material, and intended use. | |
| Performance Date | |
| (Nonclinical and/or | |
| Clinical): | Non-Clinical Performance and Conclusions: |
| Bench testing results demonstrate that the Synthes Zero-P is substantially | |
| equivalent to the predicate devices. | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
1
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 with three wing-like shapes, symbolizing service and protection. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes Spine % Ms. Stacey Bonnell Associate Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, PA 19380
SEP 12 2011
K072981 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: January 15, 2008 Received: January 16, 2008
Dear Ms. Bonnell:
Re:
This letter corrects our substantially equivalent letter of February 11, 2008.
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 (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.
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
3
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K172981 / Peps / 1 / 7 / 1
@ SYNTHES® Spine
Indications for Use Statement
510(k) Number: K072981 (if known)
Device Name: Synthes Zero-P
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 な (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)
Barbora Boucims
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072981