(378 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-TI. 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 (ASTM F2026) spacer with a radiopaque marker (ASTM F136-2a), a titanium alloy anterior plate and screws (ASTM F F1295). 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. This line extension covers the addition of sterile screws.
The provided text is a 510(k) summary for the Synthes Zero-P, an intervertebral fusion device. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets them. Instead, it explicitly states:
"Mechanical and clinical data and conclusions were not needed for this device. The enclosed information demonstrates the subject device is as safe, effective and performs as well as the predicate."
Therefore, based on the provided document, I cannot fulfill the request as it asks for information that is not present. The document indicates that a study for acceptance criteria was not required for this specific filing.
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K093762
Image /page/0/Picture/1 description: The image shows the Synthes Spine logo. The logo consists of the Synthes symbol, the word "SYNTHES" in bold, and the word "Spine" in a smaller, italicized font. The Synthes symbol is a circle with a stylized "S" inside.
DEC 2 0 2010
| 510(k) Summary | |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Amnon TalmorRegulatory Affairs SpecialistTelephone: 610-719-5446Facsimile: 610-719-5102Email: talmor.amnon@synthes.com |
| Date Prepared: | November 29, 2010 |
| Trade Name: | Synthes Zero-P |
| Common Name: | Intervertebral fusion device |
| Classification: | 21 CFR 888.3080 Intervertebral fusion deviceClass II (special controls)Orthopaedic and Rehabilitation Devices PanelProduct Code: ODP |
| Predicate Device: | Synthes Zero-P System is substantially equivalent to the SynthesZero-P System (K072981). |
| Device Description: | The Synthes Zero-P is a radiolucent and radiopaque cervicalintervertebral body fusion device. The Zero-P is composed of aPEEK (ASTM F2026) spacer with a radiopaque marker (ASTMF136-2a), a titanium alloy anterior plate and screws (ASTM FF1295). The screws are inserted through the plate into theadjacent vertebral bodies and lock securely to the plate using atapered-thread locking mechanism.The Synthes Zero-P is available as assembled components invarious heights and geometries to suit individual pathology andanatomical conditions. This line extension covers the addition ofsterile screws. |
| Intended Use /Indications for Use: | The Synthes Zero-P is a stand-alone anterior cervical interbodyfusion device indicated for use in skeletally mature patients withdegenerative disc disease (DDD) with accompanying radicularsymptoms at one level from C2-TI. DDD is defined as discogenicpain with degeneration of the disc confirmed by history andradiographic studies. These patients should have had six weeksof non-operative treatment. The interior of the spacer componentof the Synthes Zero-P should be packed with autogenous bonegraft and implanted via an anterior approach. |
| Comparison of thetechnologicalcharacteristics ofthe device to the | The Synthes Zero-P device is substantially equivalent to itspredicates in indications, fundamental scientific technology,material, mechanical performance, surgical technique, screwfixation and design. |
| predicate device: | |
| Performance Data(Nonclinical and/orClinical) | Mechanical and clinical data and conclusions were not needed forthis device. The enclosed information demonstrates the subjectdevice is as safe, effective and performs as well as the predicate. |
Special 510(k) - Synthes Zero-P Line Extension
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K0937G2
Image /page/1/Picture/1 description: The image shows the logo for Synthes Spine. The logo consists of the Synthes symbol, which is a circle with a stylized "A" inside, followed by the word "SYNTHES" in bold, sans-serif font. Below the word "SYNTHES" is the word "Spine" in a smaller, italicized font.
Image /page/1/Picture/3 description: The image shows the text "Pg 2 of 2" written in a handwritten style. The text indicates that it is page 2 of a document with a total of 2 pages. The handwriting is clear and legible, with each character easily distinguishable.
Special 510(k) - Synthes Zero-P Line Extension
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes Spine % Mr. Amnon Talmor Spine Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, PA 19380
Re: K093762
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 29, 2010 Received: November 30, 2010
Dear Mr. Talmor:
This letter corrects our substantially equivalent letter of December 20, 2010.
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. Milkensen
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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4 Indications for Use Statement
K 093762 510(k) Number: DEC 2 0 2010 (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-TI. 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 × (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-C ) Division of Surgical, Orthopedic, ad Restorative Devices
510(k) Number___K093762
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Special 510(k) - Synthes Zero-P Line Extension
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§ 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.