SYNTHES SYNEX SPACER SYSTEM

K003836 · Synthes · MQP · May 29, 2001 · Orthopedic

Device Facts

• Record ID: K003836
• Device Name: SYNTHES SYNEX SPACER SYSTEM
• Applicant: Synthes
• Product Code: MQP · Orthopedic
• Decision Date: May 29, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SynExTM Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SynEx™ Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the SynExTM Spacer System can be packed with bone.

Device Story

SynEx Spacer is a cylindrically-shaped titanium vertebral implant with a hollow core and perforated walls/endplates; designed for vertebral body replacement in thoracolumbar spine (T1-L5). Implant features two telescoping end pieces and a locking ring; endplates include teeth and spikes to resist expulsion. Surgeon expands implant vertically via self-locking ratchet mechanism; shoulder on inner piece prevents over-expansion. Interior is packed with bone graft material to facilitate fusion. Device requires use of supplemental internal fixation (e.g., Synthes ATLP, VentroFix, USS). Used by surgeons in clinical settings to provide anterior spinal column support for collapsed, damaged, or unstable vertebrae caused by tumor or trauma.

Clinical Evidence

Bench testing only. Mechanical testing was performed in accordance with the FDA's 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s' (September 2000).

Technological Characteristics

Material: Titanium alloy Ti6A17Nb (ASTM F1295 / ISO 5832-11). Design: Cylindrical, telescoping, hollow-core vertebral implant with self-locking ratchet mechanism. Connectivity: None. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used with supplemental internal fixation.

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

• Depuy AcroMed Stackable Cage System (K001340)
• Depuy AcroMed Stackable Cage System (K990148)

Submission Summary (Full Text)

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# Synthes Spine 510(k) Premarket Notification Synthes SynEx™ Spacer

MAY 2 9 2001 Summary of Safety and Effectiveness Information SPONSOR: Synthes Spine Company, L. P. 1690 Russell Road Paoli, PA 19301 [phone] Contact: Jonathan Gilbert Synthes Synex™ Spacer System DEVICE NAME: CLASSIFICATION: Per CFR 21, §888.3060: Implant, fixation, spinal intervertebral body fixation orthosis devices. Class II. Product code is MQP. The Panel code is 87. PREDICATE DEVICE: Depuy AcroMed Stackable Cage System - K001340 - K990148 The SynEx device is a cylindrically-shaped titanium vertebral implant DEVICE with a hollow core; the walls and endplates have a plurality of holes. DESCRIPTION: Each implant consists of two telescoping end pieces and a locking ring. The plurality of holes and hollow core allow for the use of grafting materials to help achieve solid fusion. To resist expulsion, the implant endplates have teeth and small spikes to grip the endplates of the adjacent vertebrae. The implant can be expanded vertically using the self-locking ratchet mechanism. A shoulder on the inner telescoping piece will not pass through the locking ring, preventing over-expansion of the implant. The SynEx device is available in a variety of geometries and sizes. This enables the surgeon to choose the configuration suited to the individual pathology and anatomical condition. Only one SynEx device is to be implanted per spinal level. The interior of the spacer is open and can be packed with bone graft material. The Synex Spacer implant is intended only for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Synex™ Spacer implant include SYNTHES plate and rod systems (e.g., ATLP, VentroFix, USS). INTENDED USE: The SynExTM Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SynEx™ Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the SynExTM Spacer System can be packed with bone. Confidential 13 March 6, 2001

KOO 3836

Place 2

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# Synthes Spine 510(k) Premarket Notification Synthes SynEx™ Spacer

The SynEx™ Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

All components of the Synex™ Spacer are manufactured from MATERIAL: titanium alloy Ti6A17Nb (ASTM F1295) / ISO 5832-11.

PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 was presented.

BASIS OF SUBSTANTIAL EQUIVALENCE: The Synthes Synex™ Spacer implants are similar to the components of previously cleared spinal systems (K990148 & K001340) with respect to certain technical characteristics. The supplemental fixation devices intended for use with the Synthes Synex™ Spacer are currently cleared for use in patients with either tumor, trauma or fractures.

Date revised: 2/21/01

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

MAY 2 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jonathan Gilbert Senior RA Associate Synthes Spine 1690 Russell Road Paoli, Pennsylvania 19301-1262

Re: K003836 Trade Name: SynEx™ Spacer Product Code: MQP Regulation: 888.3060 Class: II Dated: March 7, 2001 Received: March 9, 2001

Dear Mr. Gilbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jonathan Gilbert

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Bismillahi Rahmani Ra

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Synthes Spine 510(k) Premarket Notification Synthes SynEx™ Spacer

#### Indications for Use Statement

Page 1 of 1

K003836 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Synthes SynEx™ Spacer Device Name:

### INDICATIONS:

The SynEx™ Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The SynEx™ Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the SynEx™ Spacer System can be packed with bone.

The SynEx™ Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) X

OR

Over-The-Counter Use

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(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) NumberKOQ3836