Who is the manufacturer of SYNFIX-LR?

Synthes Spine Co.Lp filed the 510(k) submission for SYNFIX-LR (K053508).

What is the FDA product code for SYNFIX-LR?

MQP. It is classified under 21 CFR 888.3060 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for SYNFIX-LR?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SYNFIX-LR?

Synthes Vertebral Spacer (K011037); Stryker Spine AVSTM PL PEEK Spacer (K050624).

Who can help prepare an FDA 510(k) submission like SYNFIX-LR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SYNFIX-LR

K053508 · Synthes Spine Co.Lp · MQP · Feb 13, 2006 · Orthopedic

Device Facts

Record ID	K053508
Device Name	SYNFIX-LR
Applicant	Synthes Spine Co.Lp
Product Code	MQP · Orthopedic
Decision Date	Feb 13, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3060
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

SynFix-LR is a vertebral body replacement device providing structural stability in the thoracolumbar spine (T1-L5) post-corpectomy. Device consists of a radiolucent/radiopaque spacer with internal cavities for bone graft (autograft/allograft) and an integrated anterior plate. Four screws are inserted through the plate into adjacent vertebral bodies and secured via a tapered thread locking mechanism. Used in conjunction with Synthes supplemental internal fixation systems (e.g., ATLP, TSLP, VentroFix, USS). Implanted by surgeons in an OR setting to restore spinal column support. Benefits include stabilization of the anterior spinal column in patients with collapsed or damaged vertebrae due to tumor or trauma.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Vertebral body replacement device; combination radiolucent and radiopaque materials; features an integrated anterior plate with four-screw fixation; tapered thread locking mechanism; available in various heights and geometries; intended for use with supplemental internal fixation systems.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) following partial or total vertebrectomy due to tumor or trauma (fracture).

Regulatory Classification

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.

Predicate Devices

Synthes Vertebral Spacer (K011037)
Stryker Spine AVSTM PL PEEK Spacer (K050624)

Related Devices

K062083 — SYNFIX -LR · Synthes Spine Co.Lp · Apr 3, 2007
K061380 — RETAIN RADIOLUCENT SPACER · Globus Medical, Inc. · Jun 8, 2006
K121107 — FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) · Globus Medical, Inc. · Jul 3, 2012
K031302 — SUSTAIN SPACER · Globus Medical, Inc. · Jun 27, 2003
K040284 — SUSTAIN RADIOLUCENT SPACER · Globus Medical, Inc. · Mar 23, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ FEB 1 3 2006 | Name of Firm: | Synthes Spine 1302 Wrights Lane East West Chester, PA 19380 | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510 (k) Contact: | Angela Mikroulis, R.A.C. Regulatory Affairs Project Manager Phone: (610) 719-5718 Fax: (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: | MQP 21 CFR 888.3060 Class II | | Predicate: | K011037- Synthes Vertebral Spacer K050624- Stryker Spine AVSTM PL PEEK Spacer | | Device Description: | 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. | | Intended Use/ Indications for Use: | 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 | ## 510 (k) Summary . {1}------------------------------------------------ | 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). | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ ## 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 23 (Division Sign-Off) (Division Sign-Onal Restorative, Division of Ogical Devices 510(k) Number_