(59 days)
The SynFixTM-LR is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedure due to tumor or trauma (i.e., fracture). The SynFixTM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer component of the SynFixTM-LR can be packed with bone (autograft or allograft). SynFixTM-LR is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Synthes SynfixTM-LR is a combination radiolucent and radiopaque vertebral body replacement device to provide structural stability in skeletally mature individuals following corpectomy. The SynfixTM-LR may be used to accommodate the anatomical requirements of the space created by the corpectomy. Four screws are inserted through the anteriorly located plate into the neighboring vertebral bodies and lock securely to the plate using a tapered thread locking mechanism. The SynFixTM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer has openings that can be packed with bone (autograft or allograft). The SynfixTM-LR is available as assembled components in various heights and geometrics to suit the individual pathology and anatomical conditions.
This document is a 510(k) summary for the SynFixTM-LR, a spinal intervertebral body fixation orthosis. As such, it does not contain any information about acceptance criteria or specific studies proving device performance against such criteria.
The document states that substantial equivalence was demonstrated based on comparison to a previously cleared vertebral replacement device (K011037). This typically means that the new device has similar technological characteristics and comparable performance to the predicate device, but specific performance metrics and acceptance thresholds are not provided in this summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, MRMC studies, or standalone performance for the SynFixTM-LR based on the provided text.
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FEB 1 3 2006
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
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| 510 (k) Contact: | Angela Mikroulis, R.A.C.Regulatory Affairs Project ManagerPhone: (610) 719-5718Fax: (610) 719-5102 |
| Trade Name: | SynFixTM-LR |
| Date Prepared: | November 30, 2005 |
| Common / Classification Name: | Spinal intervertebral body fixation orthosis |
| Device Product Code and Classification: | MQP21 CFR 888.3060Class II |
| Predicate: | K011037- Synthes Vertebral SpacerK050624- Stryker Spine AVSTM PL PEEK Spacer |
| Device Description: | The Synthes SynfixTM-LR is a combination radiolucent andradiopaque vertebral body replacement device to providestructural stability in skeletally mature individuals followingcorpectomy.The SynfixTM-LR may be used to accommodate the anatomicalrequirements of the space created by the corpectomy. Fourscrews are inserted through the anteriorly located plate into theneighboring vertebral bodies and lock securely to the plate usinga tapered thread locking mechanism. The SynFixTM-LR isintended to be used with Synthes supplemental internal fixationsystems, e.g. ATLP, TSLP, VentroFix or USS. The interior ofthe spacer has openings that can be packed with bone (autograftor allograft).The SynfixTM-LR is available as assembled components invarious heights and geometrics to suit the individual pathologyand anatomical conditions. |
| Intended Use/ Indications for Use: | The SynFixTM-LR is a vertebral body replacement deviceintended for use in the thoracolumbar spine (T1-L5) to replace acollapsed, damaged, or unstable vertebral body resected orexcised during partial and total vertebrectomy procedure due totumor or trauma (i.e., fracture). The SynFixTM-LR is intended tobe used with Synthes supplemental internal fixation systems, e.g.ATLP, TSLP, VentroFix or USS. The interior of the spacercomponent of the SynFixTM-LR can be packed with bone(autograft or allograft).SynFixTM-LR is designed to provide anterior spinal column |
510 (k) Summary
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| Substantial Equivalence: | Documentation has been provided that demonstrates that the SynFix TM -LR device is substantially equivalent (SE) to the previously cleared vertebral replacement device (K011037). |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing the bird's body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2006
Angela Mikroulis, R.A.C. Regulatory Affairs Project Manager Synthes Spine Co. L.P. 1302 Wrights Lane East West Chester, PA 19380
Re: K053508
Trade/Device Name: SynFix™-LR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 15, 2005 Received: December 16, 2005
Dear Ms. Mikroulis:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bector 3 rQxy press. Is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tise stated in the encrosule) to regally manation posice Americal Device American be on the only Food. Dava commerce prior to May 20, 1970, the enavations of the Federal Food. Drug. devices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the dovrees, soojeet to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller "Entroling may of the 898. In addition, FDA may oc found in the Out or events concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination and of the Ad Please be advised that I DA s issuation of a because of a benefits with other requirements of the Act that IDA has made a decornmancer an administered by other Federal agencies. You must or any Federal statutes and regulations annuding, but not limited to: registration and listing (21 Colliply with an the Act 3 requirements, moraans, 2017, 2011, 2011 manufacturing practice requirements as set
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Page 2 – Ms. Angela Mikroulis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) regalates) (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-105 product radiation control provisions (Doctoris 991 - vice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device to and suice to Jogo I his letter will anow you to begin makemig your antial equivalence of your device to a legally premarket notification. The PDA miding of backantal equate and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your device on our case note the regulation entitled, the more a bissing Conlier the Office of Compliance at (210) 216 - 16 - 16 - 16 - 10 - 10 - 10 - 16 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -" Misbranding by relevence to premantee noulities. In the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Fibersity of Carbider Station of Support/index.html.
Sincerely yours,
So Mark N. Melkerson
Acting Director
Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): Kx(x3 3 SOS
Device Name: SynFixTM-LR
Indications for Use:
The SynFix™-LR is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised Spine (11 25) to replal vertebrectoniy procedure due to tumor or trauma (i.e., fracture). The SynFix™-LR is intended to be used with Synthes supplemental internal fixation systems, org. ATLP, TSLP, Ventrolix or USS. The interior of the spacer component of the SynFix™-LR can be packed with bone (autograft or allograft).
SynFix™-LR is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Prescription Use X (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of a
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(Division Sign-Off) (Division Sign-Onal Restorative, Division of Ogical Devices
510(k) Number_
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.