SYNTHES T-PAL SPACER

K100089 · Synthes Spine · MAX · May 13, 2010 · Orthopedic

Device Facts

• Record ID: K100089
• Device Name: SYNTHES T-PAL SPACER
• Applicant: Synthes Spine
• Product Code: MAX · Orthopedic
• Decision Date: May 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. *The T-PAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, Synthes USS (including Matrix, USS Small Stature Click'X, Pangea, USS Polyaxial, USS Iliosacral, and ClampFix).

Device Story

Radiolucent interbody fusion device; used in conjunction with supplemental fixation for spinal stabilization. Implant features pyramidal teeth for construct stabilization; bullet-nose design for self-distraction and insertion; open architecture for autogenous bone graft packing. Available in two footprints and various heights; lordotic angulation (5°) to accommodate spinal curvature. Used by surgeons in clinical settings during spinal fusion procedures. Provides structural support to intervertebral space; facilitates fusion; benefits patients by addressing discogenic back pain.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Radiolucent intervertebral body fusion device; open architecture for bone graft; pyramidal teeth for stabilization; bullet-nose design; 5° lordotic angle options.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 requiring interbody fusion with supplemental fixation, following six months of failed non-operative treatment.

Regulatory Classification

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.

Special Controls

*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.

Reference Devices

• TSLP
• ATB
• Antegra
• Pangea
• Synthes USS (including Matrix, USS Small Stature Click'X, Pangea, USS Polyaxial, USS Iliosacral, and ClampFix)

Submission Summary (Full Text)

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## 510(k) Summary

# MAY 1 8 2010

:

| 510(k) Summary -T-PAL Spacer | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Firm: | Synthes Spine<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
| 510(k) Contact: | Heather Guerin, Ph.D., P.E.<br>Regulatory Affairs Specialist<br>Telephone: [phone] Facsimile: 610-719-5102<br>Email: [e-mail] |
| Date Prepared: | May 12, 2010 |
| Trade Name(s): | Synthes T-PAL Spacer |
| Classification: | 21 CFR 888.3080 - Spinal Intervertebral Body Fusion Device<br>Class II (Special Controls)<br>Orthopaedic and Rehabilitation Devices Panel (87)<br>Product Code MAX (orthosis, spinal intervertebral fusion) |
| Predicates: | Synthes T-PAL Spacer is substantially equivalent to similar previously<br>cleared predicate devices. |
| Device<br>Description(s): | The Synthes T-PAL Spacer is a radiolucent interbody fusion device used<br>in conjunction with supplemental fixation to provide structural stability in<br>skeletally mature individuals following total or partial discectomy. The T-<br>PAL Spacer is available in two footprints and a range of heights, and is<br>angulated 5º to accommodate the lordotic curve (except for the smallest<br>height of each footprint, which does not have a lordotic angle). Pyramidal<br>teeth that assist in stabilization of the construct are located on the inferior<br>and superior surfaces of the spacers. These teeth are oriented along a<br>contour that follows the curve of the implant to assist in implantation. A<br>bullet-nose design also facilitates self-distraction and ease of insertion.<br>The open architecture of the devices allows them to be packed with<br>autogenous bone graft material, i.e., autograft. |
| Intended Use/<br>Indications for<br>Use: | Synthes T-PAL Spacer is indicated for use in patients with degenerative<br>disc disease (DDD) at one or two contiguous levels from L2 to S1 whose<br>condition requires the use of interbody fusion combined with<br>supplemental fixation. The interior of the T-PAL Spacer should be<br>packed with autogenous bone graft (i.e. autograft). DDD is defined as<br>back pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies. These patients should be skeletally<br>mature and have had six months of non-operative treatment.<br>*The T-PAL Spacer is intended to be used with Synthes supplemental<br>fixation, e.g. TSLP, ATB, Antegra, Pangea, Synthes USS (including<br>Matrix, USS Small Stature Click'X, Pangea, USS Polyaxial, USS<br>Iliosacral, and ClampFix). |
| 510(k) Summary -T-PAL Spacer | |
| the device to<br>predicate<br>device(s): | design, function, performance, material, and intended use. |
| Performance<br>Date<br>(Non-Clinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Based the below listed performance tests, Synthes has determined that the<br>Synthes T-PAL Spacer is substantially equivalent to the predicate devices:<br>• Static Axial Compression<br>• Dynamic Axial Compression<br>• Subsidence<br>• Expulsion<br>• Static Compression Shear<br>Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for this device. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird symbol, with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 8 2010

Synthes Spine % Ms. Heather Guerin, Ph.D., P.E. Regulatory Affairs Specialist 1302 Wrights Lane East Wet Chester, Pennsylvania 19380

Re: K100089

Trade/Device Name: Synthes T-PAL Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 16, 2010 Received: April 19, 2010

Dear Dr. Guerin:

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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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 Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Heather Guerin, Ph.D., P.E.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Barbara Brelun

Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

T-PAL Spacer

@ SYNTHES. Spine

510(k) Number(s): K100089 (if known)

Device Name: Synthes T-PAL Spacer

Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

*The T-PAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, Synthes USS (including Matrix, US\$ Small Stature Click'X, Pangea, USS Polyaxial, USS Iliosacral, and ClampFix).

X 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)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K100089