(111 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 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.
This device, the Synthes Zero-P, is an intervertebral fusion device. The provided text indicates that no clinical data was needed for this device. Therefore, a study demonstrating the device meets acceptance criteria via clinical performance data does not exist in this submission as it was not required.
Instead, the performance data cited is non-clinical, specifically "Bench testing results demonstrate that the Synthes Zero-P is substantially equivalent to the predicate devices." This implies that the acceptance criteria for this device were met through demonstrating equivalence in design, function, and materials to already approved predicate devices via non-clinical, benchtop testing, rather than through a clinical study with human subjects.
Given that no clinical study was performed, the following information cannot be provided from this submission:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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Ko72981
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510(k) Summary
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Susan LewandowskiManager, Spine Regulatory AffairsTelephone: 610-719-5712Facsimile: 610-719-5102Email: lewandowski.susan@synthes.com |
| Date Prepared: | January 15, 2008 |
| Trade Name: | Synthes Zero-P |
| Classification: | 21 CFR 888.3080 - Intervertebral fusion deviceClass 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 intervertebralbody fusion device. The Zero-P is composed of a PEEK spacer with aradiopaque marker, a titanium alloy anterior plate and screws. The screwsare inserted through the plate into the adjacent vertebral bodies. Thescrews lock securely to the plate using a tapered-thread lockingmechanism. The Synthes Zero-P is available as assembled components invarious heights and geometries to suit individual pathology and anatomicalconditions. |
| Intended Use/Indications for Use: | The Synthes Zero-P is a stand-alone anterior cervical interbody fusiondevice indicated for use in skeletally mature patients with degenerativedisc disease (DDD) with accompanying radicular symptoms at one levelfrom C2-T1. DDD is defined as discogenic pain with degeneration of thedisc confirmed by history and radiographic studies. These patients shouldhave had six weeks of non-operative treatment. The interior of the spacercomponent of the Synthes Zero-P should be packed with autogenous bonegraft and implanted via an anterior approach. |
| Comparison of thedevice to predicatedevice(s): | The Synthes Zero-P is substantially equivalent to the predicates in design,function, material, and intended use. |
| Performance Date(Nonclinical and/orClinical): | Non-Clinical Performance and Conclusions: |
| Bench testing results demonstrate that the Synthes Zero-P is substantiallyequivalent to the predicate devices. | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
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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
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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
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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
§ 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.