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 Description

The Synthes T-PAL Spacer is a radiolucent interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. The T-PAL Spacer is available in two footprints and a range of heights, and is angulated 5º to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle). Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. These teeth are oriented along a contour that follows the curve of the implant to assist in implantation. A bullet-nose design also facilitates self-distraction and ease of insertion. The open architecture of the devices allows them to be packed with autogenous bone graft material, i.e., autograft.

AI/ML Overview

The provided 510(k) summary describes a spinal intervertebral body fusion device, not an AI or imaging device. Therefore, many of the requested criteria related to AI or digital imaging performance metrics (like sample size for test/training set, expert qualification, MRMC studies, standalone performance, etc.) are not applicable and thus, no information is available in the provided text for those points.

This submission focuses on the mechanical and structural performance of the T-PAL Spacer, comparing it to predicate devices through non-clinical performance tests.

Here's the available information based on the provided text:

Acceptance Criteria and Device Performance

Criteria	Description / Reported Performance
Non-Clinical Performance Tests	Synthes determined the T-PAL Spacer is substantially equivalent to predicate devices based on the following tests:
Static Axial Compression	Performed (conclusion: substantially equivalent)
Dynamic Axial Compression	Performed (conclusion: substantially equivalent)
Subsidence	Performed (conclusion: substantially equivalent)
Expulsion	Performed (conclusion: substantially equivalent)
Static Compression Shear	Performed (conclusion: substantially equivalent)
Clinical Performance	Not needed for this device.
Substantial Equivalence to Predicates	The device is considered substantially equivalent to similar previously cleared predicate devices in terms of design, function, performance, material, and intended use as determined by the non-clinical performance tests. This is the primary acceptance criterion for 510(k) clearance for this type of device, indicating it performs as safely and effectively as a legally marketed device.

Study Details (where applicable for a non-AI/imaging device)

Sample size used for the test set and the data provenance: Not applicable. The performance evaluation was based on non-clinical (mechanical) testing of the device itself, not on processing a defined "test set" of data or images.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance typically comes from engineering specifications and testing standards, not expert clinical consensus in this context.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/imaging device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
The type of ground truth used: The "ground truth" for this type of device is established by engineering standards and validated mechanical testing protocols. The goal is to demonstrate that the device meets or exceeds the mechanical properties and safety profiles of its predicate devices when tested under specified conditions.
The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in the conventional sense.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary

MAY 1 8 2010

510(k) Summary -T-PAL Spacer
Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Heather Guerin, Ph.D., P.E.Regulatory Affairs SpecialistTelephone: 610-719-5432 Facsimile: 610-719-5102Email: guerin.heather@synthes.com
Date Prepared:	May 12, 2010
Trade Name(s):	Synthes T-PAL Spacer
Classification:	21 CFR 888.3080 - Spinal Intervertebral Body Fusion DeviceClass II (Special Controls)Orthopaedic and Rehabilitation Devices Panel (87)Product Code MAX (orthosis, spinal intervertebral fusion)
Predicates:	Synthes T-PAL Spacer is substantially equivalent to similar previouslycleared predicate devices.
DeviceDescription(s):	The Synthes T-PAL Spacer is a radiolucent interbody fusion device usedin conjunction with supplemental fixation to provide structural stability inskeletally mature individuals following total or partial discectomy. The T-PAL Spacer is available in two footprints and a range of heights, and isangulated 5º to accommodate the lordotic curve (except for the smallestheight of each footprint, which does not have a lordotic angle). Pyramidalteeth that assist in stabilization of the construct are located on the inferiorand superior surfaces of the spacers. These teeth are oriented along acontour that follows the curve of the implant to assist in implantation. Abullet-nose design also facilitates self-distraction and ease of insertion.The open architecture of the devices allows them to be packed withautogenous bone graft material, i.e., autograft.
Intended Use/Indications forUse:	Synthes T-PAL Spacer is indicated for use in patients with degenerativedisc disease (DDD) at one or two contiguous levels from L2 to S1 whosecondition requires the use of interbody fusion combined withsupplemental fixation. The interior of the T-PAL Spacer should bepacked with autogenous bone graft (i.e. autograft). DDD is defined asback pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies. These patients should be skeletallymature and have had six months of non-operative treatment.*The T-PAL Spacer is intended to be used with Synthes supplementalfixation, e.g. TSLP, ATB, Antegra, Pangea, Synthes USS (includingMatrix, USS Small Stature Click'X, Pangea, USS Polyaxial, USSIliosacral, and ClampFix).
510(k) Summary -T-PAL Spacer
the device topredicatedevice(s):	design, function, performance, material, and intended use.
PerformanceDate(Non-Clinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Based the below listed performance tests, Synthes has determined that theSynthes T-PAL Spacer is substantially equivalent to the predicate devices:• Static Axial Compression• Dynamic Axial Compression• Subsidence• Expulsion• Static Compression ShearClinical Performance and Conclusions: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 (800) 638-2041 or (301) 796-7100 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

*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)

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

510(k) Number_ K100089

Regulation Number and Section

§ 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.