The PASS LP Spinal System includes a pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Description

The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, clamps, rods, nuts, rod plates and crosslink members. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

AI/ML Overview

The provided text describes a Special 510(k) submission for the PASS LP Spinal System, focusing on modifications to connectors. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a mechanical device, not an AI/algorithm-based one.

Specifically, the document states:

Performance Data: "When applicable, the tests performed on the additional components according to ASTM F1798, indicate that the products are as mechanically sound as other devices commercially available."

This statement confirms that some mechanical testing was done according to ASTM F1798, but it does not provide acceptance criteria or detailed study results. AI/algorithm-related criteria or studies are not relevant to this device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as the provided text pertains to a mechanical spinal system and not an AI-based device. The original request's parameters (e.g., sample size for test set, number of experts, adjudication method, AI assistance, ground truth) are designed for AI/algorithm-based devices and are not applicable here.

Summary

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SPECIAL 510(K) SUMMARY

2008
KAZO

1. GENERAL INFORMATION

Trade Name	PASS LP Spinal System
Common Name	✓ Posterior pedicle screw system✓ Hooks✓ Sacral plate
Classification Name	✓ orthosis, spinal pedicle fixation per MNI 888.3070✓ orthosis, spondylolisthesis spinal fixation per MNH 888.3070
Class	Class II
Product Code	MNI / MNH
CFR section	888.3070
Device panel	Orthopedic
Legally marketed predicate devices	The PASS LP Spinal System angulated and offset connectors are substantially equivalent to similar previously cleared PASS connecting clamps (K080099).
Reason for Special 510(k)	Product range extension and additional components
Submitter	MEDICREA® TechnologiesZ.I. Chef de Baie17000 La Rochelle, France
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199E-Mail: ortho.medix@sbcglobal.net

2. PREDICATE DEVICE DESCRIPTION

3. DESCRIPTION OF DEVICE MODIFICATION

The purpose of this submission is to make modifications to the PASS LP Spinal System. Compared to the PASS standard connecting cleared in K080099, this connector extends from the rod to the screw in an angulated direction (angulated connector) or the distance from the rod to the screw is increased (offset connector).

4. INTENDED USE

5. PERFORMANCE DATA

When applicable, the tests performed on the additional components according to ASTM F1798, indicate that the products are as mechanically sound as other devices commercially available.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicrea Technologies % The Orthomedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K083308

Trade/Device Name: PASS LP Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: November 6, 2008 Received: November 10

DEC 10 2007

Dear Mr. Webb:

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 - Mr. J.D. Webb

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

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 (if known): _ KO& 3308

Device Name: PASS LP Spinal System

PASS LP Spinal System Indications for Use

The PASS LP Spinal System includes a pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

and Neurologi

510(k) Number K083308

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Regulation Number and Section

N/A