LTD POLYAXIAL FIXATION SYSTEM by US SPINE

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) 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 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 back pain 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) tumor 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 allow described by such standards at ASTM F67 or ASTM F136 for ISO 5832-2/3.

This Pre-market Notification adds 5.5mm rods and associated polyaxial screws to the LTD Polyaxial System.

AI/ML Overview

The provided text describes the 510(k) summary for the LTD Polyaxial Fixation System, a spinal fixation device. The study described focuses on biomechanical testing to demonstrate the device's mechanical integrity and performance, rather than clinical efficacy or diagnostic accuracy. Therefore, many of the typical acceptance criteria and study design elements for AI/diagnostic devices (e.g., sample size for test sets, ground truth establishment, MRMC studies) are not applicable here.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list numerical "acceptance criteria" for each performance metric in a table format, nor does it provide specific "reported device performance" values beyond a general statement of meeting acceptance criteria. This is common for predicate device submissions where the focus is on demonstrating equivalence to already marketed devices through similar testing.

However, the "Performance Data" section indicates the types of tests conducted and a general statement of their success:

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Static Axial Compression Bending Test	Met the acceptance criteria (implying performance within established limits for predicate devices)	Met the acceptance criteria
Static Torsion Test	Met the acceptance criteria (implying performance within established limits for predicate devices)	Met the acceptance criteria
Dynamic Axial Compressing Bending Test	Met the acceptance criteria (implying performance within established limits for predicate devices)	Met the acceptance criteria

Note: The specific numerical acceptance limits for these biomechanical tests are not provided in the summary. For spinal fixation devices, these limits are typically derived from standards (e.g., ASTM, ISO) or established by comparison to predicate devices, ensuring the device can withstand physiological loads without failure.

Study Details

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of this biomechanical testing. The "test set" would refer to the number of device components or constructs tested. The specific number of samples tested for each biomechanical test (e.g., number of rods, screws, or constructs) is not specified in this summary.
Data Provenance: Not applicable. Biomechanical tests are laboratory-based and do not involve human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a biomechanical study, not a study requiring expert interpretation or ground truth establishment based on human or biological data. The "ground truth" in this context would be the physical properties and performance characteristics of the materials and device constructs as measured by specialized testing equipment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. As this is biomechanical testing, no expert adjudication is involved.

5. 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 study involving human readers or AI assistance. It is a biomechanical performance study of a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. There is no algorithm or AI involved in this device or its testing as described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Mechanical Performance Standards/Specifications: The "ground truth" or reference for passing these tests would be the established industry standards (e.g., ASTM F1717-96 for Spinal Implant Constructs, which often specifies testing methods and acceptance criteria) or the measured performance of legally marketed predicate devices. The device is expected to meet or exceed these established benchmarks for strength and durability.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning study.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" or corresponding ground truth establishment process for this type of device submission.

Summary

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K662785

510(k) Summary

Manufacturer:	US Spine3600 FAU Blvd., Suite 101Boca Raton, FL 33431	DEC 26 2006
Submitted By:	Richard Jansen, Pharm. D.Silver Pine Consulting13540 Guild Ave.Apple Valley, MN 55124Phone 952-431-5999Fax 952-432-3245richj@s-pineconsulting.com
Proprietary Name:	LTD Polyaxial Fixation System
Classification Name:	Appliance, Fixation, Spinal
Common/Usual Name:	Pedicle Screw Spinal System
Classification:	Class II (888.3050, 888.3060, 888.3070)
Product Codes:	MNH, MNI, KWP, KWQ
Predicate Devices:	K980447 - Moss Miami Pedicle Fixation SystemK984251 - Stryker Spine Xia Spine SystemK031585 - Optima Spine System
Device Description:	The LTD Polyaxial Fixation System consists of a variety ofshapes and sizes of rods, screws and connectingcomponents, sold with or without the surgical instrumenttray. These components can be rigidly locked into a varietyof configurations, with each construct being tailor-made forthe individual case. The LTD Polyaxial Fixation Systemimplant components are fabricated from medical gradetitanium or titanium allow described by such standards atASTM F67 or ASTM F136 for ISO 5832-2/3.This Pre-market Notification adds 5.5mm rods andassociated polyaxial screws to the LTD Polyaxial System.
Indications for Use:	The LTD Polyaxial Fixation System is intended to helpprovide immobilization and stabilization of spinal segmentsas an adjunct to fusion of the lumbar and/or sacral spine,

Pg 1 of 2

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K612785

When used as a pedicle screw fixation system of the noncervical 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).

Biomechanical testing included a static axial compression Performance Data: bending test, static torsion test and dynamic axial compressing bending test. All tests met the acceptance criteria.

pg 2of2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

US Spine % Richard Jansen, Pharm. D Silver Pine Consulting 13540 Guild Ave Apple Valley, Minnesota 55124

DEC 26 2006

Re: K062785

Trade/Device Name: LTD 5.5 Polyaxial Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, KWQ, MNI, MNH Dated: November 22, 2006 Received: November 27, 2006

Dear Dr. Jansen:

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 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.

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Page 2 - Dr. Richard Jansen

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 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), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours.

Barbara Buchmu

Mark N. Melkerson 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: K062785

Device Name: LTD Polyaxial Pedicle Fixation System

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:

Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchud

(Division Sign-Of Division of General, Restarative, and Neurological Devices

510(k) Number K062785

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.