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:

Fractures .
Dislocation .
Failed previous fusion (Pseudoarthrosis) .
Spinal stenosis .
Degenerative spondylolisthesis with objective evidence of neurological impairment .
Spinal deformations such as scoliosis or kyphosis. .
Loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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.

The PASS LP also includes hooks and rods and sacral/iliac screws indicated for degenerative disc disease (ddd) 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), spinal stenosis, deformilies or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft . Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromiummolybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks,sacral plates, iliac screws, clamps, nuts and crosslink components.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

AI/ML Overview

This device submission (K132575) is for a modification to an existing device, the PASS LP Spinal System (K123138), by adding "Precontoured S-Rods" and "Unit Rods". As such, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than conducting a new comprehensive performance study against a specific set of acceptance criteria in the traditional sense.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Soundness (Implied)	"The products are as mechanically sound as other devices commercially"
Geometric Similarity (Implied)	"the geometry is similar to predicates devices (equivalent angles, similar diameter)"
Material Properties (Implied)	"the materials used have similar properties."

Explanation: In this 510(k) submission, the "acceptance criteria" are implied through the concept of "substantial equivalence." The sponsor asserts that the modified components (Precontoured S-Rods and Unit Rods) are equivalent to existing, legally marketed predicate devices based on their mechanical soundness, geometric similarity, and material properties. There are no explicit quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) mentioned in this document that would typically be associated with a new device's performance study. Instead, the approach is to show that the new components are comparable to already-approved ones.

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

Sample Size: Not applicable. No performance testing involving a "test set" of patient data or clinical samples was conducted.
Data Provenance: Not applicable. The demonstration of substantial equivalence was based on descriptive information and comparison to predicate devices, not on data derived from patient studies.

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

Number of Experts: Not applicable. No ground truth was established by experts for a test set in this submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set was used, and therefore no adjudication was required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No. This submission does not involve an AI device or a comparative effectiveness study with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: No. This submission does not involve an algorithm or AI device.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of clinical or diagnostic performance. For this device filing, the "ground truth" for demonstrating substantial equivalence is the established performance and safety of the predicate devices. That is, the predicate devices are considered safe and effective, and the new device components are shown to be equivalent to them.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This submission does not involve an AI device or machine learning model that requires a training set.

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

Ground Truth Establishment: Not applicable. No training set was used.

Summary of the Study:

The "study" in this context is a descriptive comparison for substantial equivalence, not a performance study in the traditional sense involving clinical data or benchmarks. The core of the demonstration is the following statement:

"Descriptive information is sufficient to demonstrate the substantial equivalence of the subject rods. No performance testing was necessary."

This means that the manufacturer presented engineering and design documentation (e.g., blueprints, material specifications, mechanical properties of the materials) for the new "Precontoured S-Rods" and "Unit Rods." They then compared this descriptive information to similar characteristics of already-approved predicate devices (PASS LP Spinal System K123138, USS, Click'X, VAS, Dual-Openin, Small Stature K022949, BacFix Spinal fixation System K983260).

The FDA's decision to clear the device (K132575) indicates that they agreed that this descriptive comparison was sufficient to establish substantial equivalence for the addition of these specific components to an existing system, and that no new performance testing (such as mechanical or clinical studies) was required.

Summary

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510{k} SUMMARY

Date Prepared	3rd of October, 2013
Submitter	MEDICREA® INTERNATIONAL14 Porte Du Grand Lyon01700 NEYRON- FRANCE
Contact	Audrey VION14 Porte du Grand Lyon01700 NEYRON - FRANCE+33 4 72 01 87 87Email: avion@medicrea.com
Trade Names	PASS LP Spinal System
Legally marketedpredicate devices	PASS LP Spinal System (MEDICREA), K123138USS, Click'X, VAS, Dual-Openin, Small Stature (SYNTHES), K022949BacFix Spinal fixation System (Spinal Concepts), K983260
Special 510k	Addition of precontoured S-Rods and Unit Rods to the components to thePASS LP Spinal Systems cleared in K123138
Classification Name	✓ orthosis, spinal pedicle fixation per MNI 888.3070✓ orthosis, spondylolisthesis spinal fixation per MNH 888.3070✓ appliance, fixation, spinal interlaminal per KWP 888.3050✓ pedicle screw spinal system, Adolescent Idiopathic Scoliosis per OSH 888.3070
Class	II
Product Code	MNI / MNH / KWP/ OSH
CFR section	888.3070

1. GENERAL INFORMATION

2. PREDICATE DEVICE DESCRIPTION

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

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3. DESCRIPTION OF DEVICE MODIFICATION

The purpose of this submission is to extend to the PASS LP Spinal System, with the addition of a new component: 'Precontoured S rods' and 'Unit rods'

4. INTENDED 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 or deformities of thoracic, lumbar, and sacral spine:

Fractures .
Dislocation .
Failed previous fusion (Pseudoarthrosis) .
Spinal stenosis .
Degenerative spondylolisthesis with objective evidence of neurological impairment .
Spinal deformations such as scoliosis or kyphosis. .
Loss of stability due to tumors.

5. Susbtantial Equivalence

The products are substantially equivalent to other devices commercially available; the geometry is similar to predicates devices (equivalent angles, similar diameter) the materials used have similar properties.

That indicates that the products are as mechanically sound as other devices commercially

Descriptive information is sufficient to demonstrate the substantial equivalence of the subject rods. No performance testing was necessary.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.

Public Health Service

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

October 3, 2013

Medicrea International Ms. Audrey Vion Regulatory Affairs Manager 14 Porte Du Grand Lyon 01700 Nevron France

Re: K132575

Trade/Device Name: PASS LP Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: OSH, MNH, MNI, K WP Dated: September 3, 2013 Received: September 6, 2013

Dear Ms. Vion:

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 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

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Page 2 - Ms. Audrey Vion

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Reportal?roblem/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.

Erin Keith

for

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

Enclosure

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STATEMENT OF INDICATION FOR USE

510(k) Number (if known): _ K132575

Device Name: PASS LP Spinal System

Indications for Use:

The PASS LP Spinal System includes a pedicle system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:

· Fractures
Distocation
. Falled previous fusion (Pseudoarthrosis)
· Spinal stenosis
· Degenerative spondylolisthesis with objective evidence of neurological impairment
. Spinal deformations such as scollosis or kyphosis.
. Loss of stability due to tumors.

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolistiesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature pattents 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 solld fusion.

The PASS LP also includes hooks and sacrafiliac screws indicated for degenerative disc disease (ddd) 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), spinal stenosis, deformities or curvatures (i.e., scollosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion,

Except for rod piates, when used for posterior non-cervical pediative screw fixation in pediative patients. The PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The PASS LP Spinal System is intended to be used with allograft. Pediatic pedicie screw fixation is limited to a posterior approach.

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)

Amy S. Graf-S

For RPJ

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132575

Page 1 of 1

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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 the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.