The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spiral tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by bark nin of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) turnor resection, and/or (7) failed previous fusion.

Device Description

The LTD Polyaxial Fixation System consists of a variety of shapes and sizes of rods, screws and connecting components, sold with or without the surgical instrument tray. These components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The LTD Polyaxial Fixation System implant components are fabricated from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2

AI/ML Overview

The provided 510(k) summary describes the LTD Polyaxial Fixation System, a spinal implant system. It presents performance testing results without defining explicit acceptance criteria in a quantitative table. The primary method for demonstrating safety and effectiveness is through substantial equivalence to predicate devices, supported by mechanical testing.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Static Axial Testing (Compression Bending)	Complies with ASTM Standard F1717-01. Substantially equivalent in static strength to predicate devices.
Static Torsion Testing	Complies with ASTM Standard F1717-01. Substantially equivalent in static strength to predicate devices.
Cyclical Axial Compression Bending (Fatigue)	Maximum run-out load value at 5.0 x 10^6 cycles estimated. Complies with ASTM Standard F1717-01. Substantially equivalent in fatigue strength to predicate devices.

Note: The document states "Results demonstrate that the LTD Polyaxial Fixation System complies with the recognized, voluntary performance standards for spinal implant systems." and "test results indicate that the LTD Polyaxial Fixation System is substantially equivalent in static and fatigue strength to predicate devices previously cleared by FDA." However, specific numerical acceptance thresholds (e.g., minimum load values, ranges) or direct comparison data to the predicate devices are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "testing" and "test results" without providing the number of units tested for each mechanical test.
Data Provenance: The study is reported as laboratory mechanical testing. The origin of the device manufacturer (U.S. Spinal Technologies, Inc.) is Boca Raton, Florida, USA. As this is a 510(k) submission, the data is prospective for this submission, conducted to demonstrate equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable: This submission relies on mechanical laboratory testing of the device components, not on expert assessment of clinical data or images. Therefore, clinical ground truth establishment by experts is not relevant to this specific study as described.

4. Adjudication Method for the Test Set

Not Applicable: As this involves mechanical testing following a standard protocol (ASTM F1717-01), there is no adjudication method in the sense of reconciling expert opinions. The validity of the test results would be determined by adherence to the standard and proper measurement techniques.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No: No MRMC study or any clinical comparative effectiveness study involving human readers is mentioned. The submission focuses on mechanical performance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable: The device is a physical spinal implant system, not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Mechanical Performance Standards: The "ground truth" for this study is defined by adherence to a recognized, voluntary performance standard (ASTM F1717-01) for spinal implant constructs in a vertebrectomy model, and demonstrating substantial equivalence in static and fatigue strength to predicate devices. The properties of the materials (medical grade titanium or titanium alloy described by ASTM F67, ASTM F136, ISO 5832-3, or ISO 5832-2) also serve as part of the "ground truth" for material specifications.

8. The Sample Size for the Training Set

Not Applicable: This is a mechanical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: As there is no training set for an AI model, this question is not relevant.

Summary

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SEP - 8 2004 510(k) Summary

Submitted on behalf of:

U.S. Spinal Technologies, Inc. 3701 FAU Blvd. Ste 210 Boca Raton, FL 33431, USA Telephone: 561-367-7463 Fax: 561-367-9627

by:

Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater. MN 55082 715-549-6035 715-549-5380

Kot 1225

CONTACT PERSON:

Telephone:

Fax:

DATE PREPARED: June 14, 2004

Elaine Duncan

TRADE NAME:	LTD Polyaxial Fixation System
COMMON NAME:	spinal fixation system

SUBSTANTIALLY EQUIVALENT TO:

The LTD, the Moss Miami system, the Xia Spine System and the Optima Spine System are all top-loading polyaxial screws with greater than 40° variability and all four systems are made from titanium. All four systems have screws that accept a 6.0mm titanium rod. All four pedicle screws use a threaded Set Screw to lock the rod to the pedicle screw. All four systems are indicated from L5-S1 for 1) Degenerative Disc Disease, 2) Spinal Stenosis, and 3) Spondylolisthesis. [The Moss Miami and the Xia Spine System are also indicated for deformities (kyphosis/scoliosis)]. However, the Moss Miami is assembled in three pieces w screw shank, bushing and head body, where as the LTD and Xia are assembled using two pieces: screw shank and head body.

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

510(k) Submission

l of i

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510(k) Summary-Continued

SUMMARY of TESTING:

The LTD Polyaxial Fixation System was tested for: 1. Static axial testing in a load to failure mode in compression bending, 2. Static torsion testing in a load to failure mode in torsion, and 3. Cyclical axial compression bending testimate the maximum run out load value at 5.0 x 106 cycles. The the the protocol followed ASTM Standard F1717-01, "Standard Test Methods for Static and Fatisyer or Spinal Implant Constructs in a Vertebrectomy Model." Results demonstrate that the LTD Polyaxial Fixation System complies with the recognized, voluntary performance standards for spinal implant systems. In addition, test results indicate that the LTD Polyaxial Fixation System is substantially equivalert in staic and fatigue strength to predicate devices previously cleared by FDA.

f 7

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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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 8 2004

U.S. Spinal Technologies, LLC. C/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. PO Box 560 Stillwater, Minnesota 55082

Re: K041625

Trade/Device Name: LTD Polyaxial Fixation System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWQ, KWP, MNH, MNI Dated: June 14, 2004

Dear Ms. Duncan:

Received: June 15, 2004

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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

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Page 2 -- Ms. Elaine Duncan, M.S.M.E., RAC

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Mark A. Melkerson

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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Indications for Use

510(k) Number (if known): KO41625

Device Name: LTD Polyaxial Fixation System

INDICATIONS:

The LTD Polyaxial Fixation System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbarfirst sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiosraphic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

Prescription Use J J J _______________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use .........................................................................................................................................................

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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(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 General, Restorative,
Page 1 of 1 and Neurological Devices

510(k) Number K04 1625

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.