The PrimaLOKTM SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The PrimaLOKTM SP Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.

Device Description

The PrimaLOKTM SP Interspinous Fusion System is a bilateral locking plate system which attaches to the spine at the spinous processes. It is available in various interspinous heights and widths to accommodate differing anatomic requirements.

AI/ML Overview

The PrimaLOK™sp Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device for spinal fusion.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test - Modified ASTM F1717 Protocol)	Reported Device Performance
Static compression	Performs as well as or better than the predicate device
Static tension	Performs as well as or better than the predicate device
Static torsion	Performs as well as or better than the predicate device
Dynamic compression	Performs as well as or better than the predicate device
Dynamic torsion	Performs as well as or better than the predicate device

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

The document does not specify a separate "test set" in the context of clinical data or human evaluation. The performance data is derived from mechanical bench testing. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this summary for clinical evaluation. The "worst case" PrimaLOK™sp Interspinous Fusion System construct was tested, implying representative samples of the device were used for the mechanical tests.

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

Not applicable. The "ground truth" for this device's performance is established by mechanical engineering standards and measurements, not expert human assessment of images or clinical outcomes in the context of the provided information.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for human expert review of clinical data, which is not described here.

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

No. This document describes a premarket notification (510(k)) based on substantial equivalence, primarily supported by bench testing and comparison to predicate devices, not a clinical MRMC comparative effectiveness study.

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

The device is a physical medical implant. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to its evaluation.

7. The Type of Ground Truth Used

The ground truth used for assessing this device is based on mechanical engineering standards and measurements. Specifically, the performance was measured against a modified ASTM F1717 protocol, which outlines standardized tests for spinal implant constructs. The "ground truth" is the established mechanical properties required for such devices to be considered safe and effective in their intended use.

8. The Sample Size for the Training Set

No training set is applicable or described. This is a physical device evaluated through mechanical testing, not a machine learning model requiring a training set.

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

Not applicable, as no training set is described.

Summary

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AUG 1 7 2010

510(k) Summary		AUG 1
Date:	20 May 2010
Sponsor:	OsteoMed Spine Inc*3885 Arapaho RoadAddison, TX 75001
	Phone: (972) 677-4787Fax: (972) 677-4778* wholly owned subsidiary of OsteoMed LP
Contact Person:	Rebecca Ellis
	Vice President, RA/QA & Organizational Excellence
Proposed TradeName:	PrimaLOKTM SP Interspinous Fusion System
Device Classification	Class II
Classification Name:	Spinal interlaminal fixation orthosis
Regulation:	888.3050
Device Product Code:	KWP
Device Description:	The PrimaLOKTM SP Interspinous Fusion System is a bilaterallocking plate system which attaches to the spine at thespinous processes. It is available in various interspinousheights and widths to accommodate differing anatomicrequirements.
Intended Use:	The PrimaLOKTM SP Interspinous Fusion System is aposterior, non-pedicle supplemental fixation device,intended for use in the non-cervical spine (T1-S1). It isintended for plate fixation/attachment to spinous process forthe purpose of achieving supplemental fusion in thefollowing conditions: degenerative disc disease (defined asback pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies),spondylolisthesis, trauma (i.e., fracture or dislocation),and/or tumor. The PrimaLOKTM SP Interspinous FusionSystem is intended for use at one level, with bone graftmaterial and not intended for stand-alone use.
Materials:	The PrimaLOKTM SP Interspinous Fusion System componentsare manufactured from titanium alloy (Ti-6Al-4V) asdescribed by ASTM F136.
Predicate Devices:	CD Horizon® Spire Plate (Medtronic, K043053)
	Spinous Process Fusion [aka Aspen] Plate (Lanx, Inc.,K071877)

参考文献

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Technological Characteristics:

The PrimaLOKTMsp Interspinous Fusion System possesses the same technological characteristics as one or more of the predicates. These include:

basic design: bilateral locking plate, having an . interspinous cavity for bone graft that attaches to the spinous processes via spikes.
material: titanium allov. .
. sizing: plate sizes are within the range of those in the predicate systems, and
. intended use: as described above

The PrimaLOK™sp Interspinous Fusion System possesses a modified technological characteristic in that it incorporates a polyaxial gripping feature. This feature permits full boney contact regardless of variations in spinous process morphometry. As the plate is tightened onto the spinous processes, the grips seat and lock. In this final, locked position, the spikes function exactly as the predicates.

Therefore the fundamental scientific technology of the PrimaLOK™sp Interspinous Fusion System is the same as previously cleared devices.

Static compression, tension and torsion, and dynamic compression, and torsion of the worst case PrimaLOK "sp Interspinous Fusion System construct was performed according to a modified ASTM F1717 protocol. The mechanical results demonstrated that the PrimaLOK™sp Interspinous Fusion System performs as well as or better than the predicate device.

Performance Data:

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

OsteoMed L.P. % BackRoads Consulting, Inc. Karen E. Warden, Ph.D. Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141

AUG 1 7 2010

Re: K100354

Trade/Device Name: PrimaLOK™sp Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: August 06, 2010 Received: August 09, 2010

Dear Dr. Warden:

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. Iisting 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 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 - Karen E. Warden, Ph.D.

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 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 Buehrle

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

Enclosure

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K100354

Indications for Use Statement

510(k) Number:

Device Name: PrimaLOK™sp Interspinous Fusion System

Indications for Use:

The PrimaLOK™ sp Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The PrimaLOK(" sp Interspinous Fusion System is intended for use at one level, with bone graft material and not intended for stand-alone use.

Prescription Use _ X

AND/OR

Over-the-Counter Use_

(21 CFR 801 Subpart D)

(21 CFR 807 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_ K100354

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.