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, kyphosis, 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 chrome cobalt alloy whenever "wiring" may help secure the attachment of other implants.

Device Description

The LigaPASS connector connects a rod to a vertebra. This connector can independently tighten the rod and the bone anchor. The LigaPASS connector is composed by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

AI/ML Overview

The provided text describes the LigaPASS device, a temporary orthopedic implant, and its 510(k) summary for FDA approval. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the testing standards and the comparison to predicate devices, rather than explicitly stated numerical targets. The reported performance is a qualitative statement of equivalence.

Acceptance Criteria Category	Specific Criteria (Implicitly from ASTM Standards)	Reported Device Performance
Material/Design	Comparable to predicate device	"substantially equivalent"
Intended Use	Same as predicate device	"same intended use"
Indications for Use	Substantially similar to predicate device	"substantially similar indications for use"
Technological Characteristics	Substantially similar to predicate device	"substantially similar technological characteristics"
Principles of Operation	Substantially similar to predicate device	"substantially similar principles of operation"
Static Torsion Performance	Meeting or exceeding predicate device's performance under ASTM F1717	"The results of these tests indicate that the LigaPASS is equivalent to predicate devices."
Static Compression Bending Performance	Meeting or exceeding predicate device's performance under ASTM F1717	"The results of these tests indicate that the LigaPASS is equivalent to predicate devices."
Dynamic Compression Bending Performance	Meeting or exceeding predicate device's performance under ASTM F1717	"The results of these tests indicate that the LigaPASS is equivalent to predicate devices."
Static Tension Performance	Meeting or exceeding predicate device's performance under ASTM F1798	"The results of these tests indicate that the LigaPASS is equivalent to predicate devices."
Dynamic Tension Performance	Meeting or exceeding predicate device's performance under ASTM F1798	"The results of these tests indicate that the LigaPASS is equivalent to predicate devices."

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

Sample Size: The document does not specify the sample size for the non-clinical tests (e.g., how many LigaPASS devices were tested for each scenario). The tests were conducted according to ASTM standards, which would typically specify minimum sample sizes, but these details are not provided in the summary.
Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no information about country of origin for the data, nor whether it was retrospective or prospective, as these terms typically apply to clinical studies involving human patients.

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

Not applicable. The ground truth for this device's performance is established through physical mechanical testing against recognized industry standards (ASTM F1717 and ASTM F1798) and comparison to a legally marketed predicate device, not through expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable, as the evaluation is based on objective mechanical testing results against standardized criteria, not human interpretation requiring adjudication.

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

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.

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

Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily:

Mechanical Performance Data: Conformance to established ASTM standards (ASTM F1717 and ASTM F1798) for static and dynamic properties of spinal implants.
Substantial Equivalence to a Predicate Device: The performance and characteristics of the LigaPASS were compared to the Universal Clamp System (K060009), a legally marketed predicate device, to demonstrate that it is "substantially equivalent" in terms of safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI model requiring a training set.

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

Not applicable. This device is a physical product, not an AI model.

Summary

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510(K) SUMMARY

Trade Name	LigaPASS
Classification Name	Bone Fixation Cerclag
Class	Class II
Product Code	JDQ
CFR section	888.3010
Device panel	Orthopedic
Legally marketed predicate devices	Universal Clamp System (Abbott Spine)=K060009
Reason for Special 510(k)	Additional components
Submitter	MEDICREA International14 Porte du Grand Lyon01700 Neyron, France
Contact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199E-Mail: ortho.medix@sbcglobal.net

GENERAL INFORMATION 1.

2. PREDICATE DEVICE DESCRIPTION

The Universal Clamp System is a temporary orthopedic implant intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The device system is designed to be incorporated into constructs and used in conjunction with other medical implants.

The indications for use include, but are not limited to, the following applications: Spinal trauma surgery, used in sublaminar, interspinous or facet wiring techniques; Spinal reconstructive surgery, incorporated into constructs for the purpose of spinal deformities such as scoliosis, kyphosis, spondylolisthesis, etc; spinal degenerative surgery, as an adjunct to spinal fusions.

The Universal Clamp System may also be used with other medical implants made of stainless steel whenever "wiring" may help secure the attachment of other implants.

3. DEVICE DESCRIPTION

4. INTENDED USE

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, kyphosis, spondylolisthesis;

Spinal degenerative surgery, as an adjunct to spinal fusions;

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

SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The LigaPASS is similar to Universal Clamp System, as they have the same intended use, and substantially similar indications for use, technological characteristics and principles of operation.

NON-CLINICAL TEST SUMMARY

The following tests were conducted according to ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and ASTM F1798 "Standard Guide for Evaluating the Static and Fatique Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants":

Static testing in a load to failure mode in torsion 1.
Static testing in a load to failure mode in compression bending 2.
1. Dynamic compression bending testing
1. Static testing in a load to failure mode in tension
1. Dynamic tension testing

The results of these tests indicate that the LigaPASS is equivalent to predicate devices.

CLINICAL TEST SUMMARY

・

No clinical studies were performed.

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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

FEB - 1 2012

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

Medicrea International % The Orthomedix Group Mr. J.D. Webb 1001 Oak Wood Boulevard Round Rock, Texas 78681

Re: K112736

Trade/Device Name: LigaPASS Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: December 11, 2011 Received: December 29, 2011

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. 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 – Mr. J.D. Webb

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mulh M Millkura

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

Enclosure

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STATEMENT OF Indications for Use

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

K112736

LigaPASS Indications for Use

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, kyphosis, 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.

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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KI12736 510(k) Number.

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.