TranSl AxiaLIF® Plus System is intended to provide anterior stabilization of the L5-S1 or 14-S1 spinal segment (s) as an adjunct to spinal fusion. The AxiaLIF® Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion) spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at LS-SI or L4-SI in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF:

Device Description

The TranS1® AxiaLJF® Plus system is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 - S1 or L4-S1 disc space(s). The device's instruments are used for independently distracting the L5 - S1 or L4-S1 vertebral bodies and inserting bone grafi material (DBM, autograft or autologous blood) into the disc space. The device includes an anterior fixation rod that is implanted through the same approach and is used to lock the construct together.

AI/ML Overview

This document describes the Premarket Notification (510(k)) Summary for the TranS1® AxiaLIF Plus system, which is a medical device for spinal fusion. The study described focuses on demonstrating substantial equivalence to predicate devices through mechanical, biomechanical, and system testing. This is not a study assessing the clinical performance or diagnostic accuracy of an AI/ML device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

Acceptance Criteria and Device Performance (Mechanical/Biomechanical Testing)

Acceptance Criteria (Set by ASTM 1717 and Test Protocol)	Reported Device Performance (TranS1® AxiaLIF Plus)
Conformity to ASTM 1717 standard for device type	Met or exceeded requirements of ASTM 1717 and established test protocol
Static Compression Bending requirements	Met or exceeded requirements
Static Torsion requirements	Met or exceeded requirements
Fatigue Compression Bending requirements	Met or exceeded requirements
No new safety or effectiveness concerns raised	No new safety or effectiveness questions were raised

Study Details:

Sample size used for the test set and the data provenance: Not applicable. This study involved mechanical and biomechanical testing of physical implants, not a test set of patient data. The "test set" in this context refers to the physical devices and testing conditions.
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 testing is established by engineering standards (ASTM 1717) and pre-defined test protocols, not by expert consensus in the typical sense of clinical or diagnostic studies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication is not relevant for mechanical and biomechanical testing. The results are quantitative and compared against established engineering thresholds.
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 a clinical study involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a study of an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this study was established by engineering standards (ASTM 1717) and specific test protocols that define acceptable performance limits for spinal implant devices under various mechanical stresses (Static Compression Bending, Static Torsion, and Fatigue Compression Bending).
The sample size for the training set: Not applicable. There is no training set for mechanical and biomechanical testing.
How the ground truth for the training set was established: Not applicable.

Summary

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MAR 1 4 2011

Premarket Notification [510(K)] Summary (per 21 CFR 807.92)

February 7, 2011

Submitter:	TranS1, Inc.301 Government Center DriveWilmington, NC 28403	Contact Person:	Cheryl L WagonerDirector of Regulatory910-332-1703 (phone)910-332-1701 (fax)
Proprietary Name:	TranS1® AxiaLIF Plus
Classification:	21 CFR 888.3060 Spinal Intervertebral Body Fixation Orthosis, Class IIProduct Code KWQ

Predicate Device: AxiaLIF. AxiaLIF 2L+

Indications and Intended use:

TranSI AxiaLIF® Plus System is intended to provide anterior stabilization of the L5-S1 or 14-S1 spinal segment (s) as an adjunct to spinal fusion. The AxiaLIF® Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion) spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at LS-SI or L4-SI in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF:

Device Description:

Technological Characteristics and Substantial Equivalence:

Documentation was provided to demonstrate that the TranSI® AxiaLIF Plus system is substantially equivalent to the predicates AxiaLIF (K073514) and AxiaLIF 2L+ (K092124). The TranSI device is substantially equivalent to the predicate devices in intended use, level of attachment, materials, labeling, sterilization, and technological characteristics. These devices have intended use and indications and rely on the same fundamental scientific technology; therefore the Subject device is substantially equivalent to the Predicate devices.

The only significant difference from the predicate AxiaLIF 2L+ System is the use of an L5 Anchor and corresponding Fixation Rod to treat L5-S1 only instead of the longer solid L4-L5 Rod used to fixate L4-LS in addition to L5-S1 in the case of a 2 level operation. The only additional instrumentation needed for the subject AxiaLIF 11 + are unique 1 level L5 Dilator Trials used for the purpose of dilating and

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measuring for the correct implant sizes. These Dilator Trials are uniquely sized to the LS anchors and provide the same functionality as the L4-L5 Dilator Trials of the predicate AxiaLIF 2L+ System. The AxiaLIF 11,+ implant is very similar to the predicate AxiaLIF 2L+ implant with the primary difference being an L5 Anchor that only engages the L5 vertebral body instead of a longer L4-L5 Rod that engages both the L4 and L5 vertebral bodies. The Distraction Rod of the subject device which spans the L5-S1 disc space is identical to the predicate Distraction Rod of the AxiaLIF 21.+ implant and the Fixation Rod has been slightly changed on the threaded end only to allow matching thread engagement with the appropriate L5 Anchor.

The table below compares the predicate devices and the subject device.

	Predicate AxiaLIF Single Level	Predicate AxiaLIF 2L+	Subject AxiaLIF Plus
Material	Titanium-6 Aluminum-4Vanadium Alloy (Ti6Al4V), perASTM F136-02	Titanium-6 Aluminum-4Vanadium Alloy (Ti6Al4V), perASTM F136-02	Identical
Overall ConstructLengths	40mm -- 70mm	70mm - 110mm	Identical (inclusive of bothpredicates)
Diameter	L5 tip = 7.1mm; L5 base =10.9mm; S1 section = 14.0mm	L4 tip = 7.1mm; L4 base =12.9mm; L5 section = 15.5mm:S1= 15.5mm	Substantially equivalent
Shape	Tapered	Tapered	Identical
FundamentalScientific Technology	Threaded Rod	Threaded Rod	Identical

Summary of Testing:

Mechanical, biomechanical, and system testing of the TranSI AxiaLIF Plus system conforms to the ASTM 1717 standard as applicable to this device and is consistent with testing performed for the predicate devices. Testing performed for the subject device per this standard included Static Compression Bending, Static Torsion and Fatigue Compression Bending. All static and dynamic testing met or exceeded the requirements of as established by the test protocol and applicable ASTM standards. No new safety or effectiveness questions were raised as a result of the testing.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

TranS1, Inc. % Ms. Cheryl L. Wagoner Director of Regulatory 301 Government Center Drive Wilmington, North Carolina 28403

MAR 1 4 201

Re: K102334

Trade/Device Name: TranS1® AxiaLIF Plus Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 08, 2011 Received: February 11, 2011

Dear Ms. Wagoner:

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

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Page 2 - Ms. Cheryl L. Wagoner

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 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 effectionic 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Alig B. n h
for

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

Enclosure

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Page 1 of 1

510(k) Number: K102334

Device Name: TranS1® AxiaLIF Plus

Indications for Use:

TranSl AxiaLIF® Plus System is intended to provide anterior stabilization of the L5-S1 or L4-S1 spinal segment (s) as an adjunct to spinal fusion. The AxiaLIF® Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1 in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orth padic. and Restorative Devices

K102334 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.