The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for the following applications:

Spinal trauma surgery, used in sublaminar, or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis;
Spinal degenerative surgery, as an adjunct to spinal fusions;

Device Description

The LigaPASS connectors connect a rod to a vertebra. These connectors can independently tighten the rod and the bone anchor. The LigaPASS connectors are composed by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

AI/ML Overview

The MEDICREA® INTERNATIONAL LigaPASS is a temporary orthopedic implant designed to provide stabilization during spinal fusion and aid in bone fracture repair. The submission details its substantial equivalence to predicate devices, focusing on the expanded indications for use to include idiopathic and neuromuscular scoliosis treatment in patients 10 years of age and older.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (LigaPASS)
Intended Use	- Temporary stabilization as a bone anchor during solid bony fusion development.- Aid in repair of bone fractures.- Spinal trauma surgery (sublaminar or facet wiring).- Spinal reconstructive surgery for spinal deformities (scoliosis, kyphosis, spondylolisthesis).- Spinal degenerative surgery (adjunct to spinal fusions).- Used with other titanium/cobalt chrome implants for "wiring" to secure attachment.	- Same as criteria, plus expanded indication for idiopathic and neuromuscular scoliosis in patients 10 years of age and older.
Materials	- Connector: Titanium alloy (ASTM F136 or ISO 5832-3).- Band: Polyethylene terephthalate (PET) and pure titanium (ASTM F67).	- LigaPASS connectors are made from titanium alloy conforming to ASTM F136 or ISO 5832-3.- The band is manufactured from polyethylene terephthalate (PET) and pure titanium conforming to ASTM F67. (Identical to predicate and other cleared MEDICREA products).
Design/Components	- Connector with polyester band.- To circle a vertebra as a bone anchor.- Connect to a Ø5.5mm or Ø6mm rod.	- Connectors with polyester band.- To circle a vertebra as a bone anchor.- Connect to a Ø5.5mm or Ø6mm rod.- The LigaPASS connectors are composed of a connector body, a rod set screw, a locking set screw for the band, and a polyester band. (Similar design and components to the predicate device).- No other changes in terms of design characteristics, principles of operation, packaging, sterility, or biocompatibility have undergone since the previous 510(k).
Mechanical Performance	- Meets ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model".- Meets ASTM F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanism and Subassemblies Used In Spinal Arthrodesis Implants".- Comparable mechanical performance to predicate devices (Universal Clamp System K110348, LigaPASS K112736).	- Mechanical testing of LigaPASS implants was conducted following ASTM F1717 and ASTM F1798.- Data was compared to the mechanical performance of other cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736).- Mechanical performance established via these cleared devices.

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify a separate "test set" for performance evaluation in the context of clinical data. Mechanical testing was performed on LigaPASS implants, and data was compared to previously cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736). No clinical studies were conducted for this submission.
Data Provenance: The document does not provide details on the specific number of units tested for mechanical performance, or any particular provenance for those tested units (e.g., country of origin). The comparison data is derived from previously cleared predicate devices.

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

This is not applicable. No clinical studies were performed, and thus no expert-established ground truth for a clinical test set was required. The substantial equivalence claim is based on non-clinical (mechanical) testing and comparison to predicate devices, as well as material composition.

4. Adjudication Method for the Test Set

This is not applicable. As no clinical studies or human-in-the-loop evaluations were conducted, there was no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is a medical implant, and its evaluation relies on non-clinical mechanical testing and comparison to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical implant (bone fixation cerclage), not an AI algorithm or software device. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The primary "ground truth" for demonstrating acceptance was established by industry standards for mechanical testing (ASTM F1717, ASTM F1798) and the performance of legally marketed predicate devices. The material composition also relies on established standards (ASTM F136, ISO 5832-3, ASTM F67). There was no clinical ground truth (e.g., pathology, outcomes data) used as no clinical studies were conducted.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI/ML system that requires a training set.

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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510(k) Summary for the MEDICREA® INTERNATIONAL LigaPASS

1. GENERAL INFORMATION
510(k)	Traditionnal
Date Prepared	December 05, 2013
Trade Name	LigaPASS
Common Name	✓ Bone Fixation Cerclage, Sublaminar
Classification Name	✓ Bone Fixation Cerclage per OWI 888.3010
Class	Class II
Product Code	OWI
CFR section	888.3010
Device panel	Orthopedic
Legally marketed predicate devices	Universal Clamp Spinal Fixation System (Zimmer Spine)= K110348LigaPASS (MEDICREA INTERNATIONAL) = K112736
Submitter	MEDICREA International14 Porte du Grand Lyon01700 Neyron, France
Contact Person	Audrey VION14 Porte du Grand Lyon01700 NEYRONFRANCE+33(0)4 72 01 87 87E-mail : avion@medicrea.com

2. PREDICATE DEVICE DESCRIPTION

, The Universal Clamp System (K110348) and LigaPASS (K112736) are temporary orthopedic implants intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The Universal Clamp System (K110348) and LigaPASS (K112736) are designed to be incorporated into constructs and used in conjunction with other medical implants.

The indications for use for the Universal Clamp System (K110348) include, but are not limited to, the following applications: Spinal trauma surgery; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and, spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions.

The indications for use for the LigaPASS (K112736) include, but are not limited to, the following applications: Spinal trauma surgery, Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions.

The Universal Clamp System (K110348) and LigaPASS (K112736) may also be used with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

3. DEVICE DESCRIPTION

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4. INTENDED USE

The ligapass is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilziation as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for the following applications:

Spinal trauma surgery, used in sublaminar,or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis;
Spinal degenerative surgery, as an adjunct to spinal fusions;

5. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

MEDICREA® INTERNATIONAL LigaPASS is substantially equivalent to the ZIMMER SPINE Universal Clamp® System (K110348), in terms of intended use, materials used, mechanical safety and performances.

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and the state of the same of the states of the states

and the state of the same

and the comments of the country

Device	Universal Clamp® System(ZIMMER SPINE)	LigaPASS
510(k) number	K110348	In progress
Intended use	The Universal Clamp® System is atemporary implant for use inorthopedic surgery. The system isintended to provide temporarystabilization as a bone anchorduring the development of solidbony fusion and aid in the repair ofbone fractures. The indications foruse include, but are not limited to,the following applications:Spinal trauma surgery, used insublaminar, interspinous, or facetwiring techniques;Spinal reconstructive surgery,incorporated into constructs for thepurpose of correction of spinaldeformities such as scoliosis,kyphosis, spondylolisthesis;Spinal degenerative surgery, as anadjunct to spinal fusions;The universal Clamp® System mayalso be used in adjunction withother medical implants made oftitanium alloy whenever "wiring"may help secure the attachment ofother implants.	The LigaPASS is a temporaryimplant for use in orthopedicsurgery. The system is intended toprovide temporary stabilization asa bone anchor during thedevelopment of solid bony fusionand aid in the repair of bonefractures. LigaPASS system isindicated for the followingapplications:- Spinal trauma surgery, used insublaminar, or facet wiringtechniques;- Spinal reconstructive surgery,incorporated into constructs forthe purpose of correction ofspinal deformities such asidiopathic and neuromuscularscoliosis in patients 10 years ofage and older, adult scoliosis, andkyphosis;- Spinal degenerative surgery, asan adjunct to spinal fusions;LigaPASS system may also be usedin conjunction with other medicalimplant grade implants made oftitanium or cobalt chrome alloywhenever "wiring" may helpsecure the attachment of otherimplants.
Design
Components	Connector with polyester band:To circle a vertebra as a boneanchor and connect to a Ø5.5mmor Ø6mm rod.	Connectors with polyester band:To circle a vertebra as a bone anchorand connect to a Ø5.5mm or Ø6mmrod.
Range	A connector and a band.	Connectors and a band.
Materials
Device	Universal Clamp System(ZIMMER SPINE)	LigaPASS
	Universal clamp system is madefrom titanium alloy conforming toASTM F136 or ISO 5832-3, with theexception of the band which ismanufactured from polyethyleneterephtalate (PET) and puretitanium conforming to ASTM F67.	LigaPASS connectors are made fromtitanium alloy conforming to ASTMF136 or ISO 5832-3, with theexception of the band which ismanufactured from polyethyleneterephtalate (PET) and pure titaniumconforming to ASTM F67.

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Material composition is identical to other MEDICREA® INTERNATIONAL products that have been cleared via the 510(k) process.

6. NON-CLINICAL TEST SUMMARY

The LigaPASS submitted by MEDICREA in this 510(k) includes components that have been approved by the FDA in the previous 510(k) (K112736) for the following indications:

The LigaPASS is a temporary implant for use in orthopedic surgery on skeletally mature patients. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; .
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of . spinal
deformities such as scoliosis, kylphosis, spondylolisthesis;Spinal degenerative surgery, as an . adjunct to spinal fusions;

The LigaPASS may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The purpose of this new submission is to extend the indications for use to idiopathic and neuromuscular scoliosis treatment in patients 10 years of age and holder. No other changes in terms of design characteristics, principles of operation, packaging, sterility, biocompatibility or mechanical performances have undergone.

Mechanical testing of the MEDICREA - INTERNATIONAL LigaPASS implants was conducted following the ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and following the ASTM F1798 "Standard Guide for Evoluating the Static and Fotigue Properties of Interconnection Mechanism and Subassemblies Used In Spinal Arthrodesis Implants" to characterize their mechanical properties. These data was compared to the mechanical performance for other devices cleared for surgical fixation of the skeletal system (LigaPASS, MEDICREA INTERNATIONAL, K112736).

Accordingly, the mechanical performance of MEDICREA INTERNATIONAL LigaPASS implants has been established via these cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736).

7. CLINICAL TEST SUMMARY

No clinical studies were performed.

8. CONCLUSIONS: NON-CLINICAL AND CLINICAL

The LigaPASS is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 6, 2013

Medicrea International Ms. Audrey Vion Regulatory Affairs Manager 14 Porte du Grand Lyon 01700 Neyron France

Re: K132395

Trade/Device Name: LigaPASS Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: November 7, 2013 Received: November 12, 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 of medical

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Page 2 -- Ms. Audrey Vion

device-rclated 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 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" (21 CFR 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.

Lori A. Wigqins

for

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

Enclosure

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510(k) Number (if known): ___ Device Name: LigaPASS

INDICATIONS FOR USE

K132395

Spinal trauma surgery, used in sublaminar, or facet wiring techniques;
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis;
Spinal degenerative surgery, as an adjunct to spinal fusions;

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132395

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.