The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated.

Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants.
Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty.
Sternotomy indications include the "re-wiring" of sternums following osteotomy.
Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.

Device Description

The Biomet® Cable System is available in either titanium or stainless steel, consisting of a flexible, multi-strand, medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or a medical grade stainless steel (316LVM, ASTM F-138) cable. The systems are available in both single and double styles. The cable is locked into place via a pre-loaded crimp. Instruments for the Biomet® Cable System include a Cable Tensioner, a Cable Crimper, and a Cable Cutter. The titanium system is compatible with other medical grade implants made of titanium and the stainless steel system is compatible with other stainless steel implants, whenever "wiring" may help secure the attachment of other implants.

AI/ML Overview

This submission for the Biomet® Cable System (K071271) explicitly states that no clinical testing was performed as a basis for substantial equivalence. Therefore, there is no study to prove the device meets acceptance criteria based on human clinical data.

Instead, the submission relies on non-clinical laboratory testing and substantial equivalence to predicate devices. This means that the "acceptance criteria" are implied by the performance of the predicate devices and the non-clinical testing demonstrates that the Biomet® Cable System performs comparably to those predicates in a lab setting.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Performance and Non-Clinical Testing)	Reported Device Performance
Material Composition: Use of medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or medical grade stainless steel (316LVM, ASTM F-138)	Met: Biomet® Cable System is available in either medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or medical grade stainless steel (316LVM, ASTM F-138).
Design: Flexible, multi-strand cable, with pre-loaded crimp, and available in single and double styles.	Met: Biomet® Cable System consists of a flexible, multi-strand cable. The cable is locked into place via a pre-loaded crimp. The systems are available in both single and double styles.
Sizing: Comparable to predicate devices.	Met: "The technological characteristics (materials, design, sizing, indications) of the Biomet® Cable System are similar or identical to the predicate devices." (Implies comparable sizing).
Indications for Use: Comparable to predicate devices.	Met: Indications for Use are listed and deemed "similar or identical" to predicate devices. These include spinal applications, trochanteric reattachment, sternotomy, and trauma surgery.
Functional Performance: Device is functional within its intended use.	Met (Non-Clinical): "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
Compatibility: Titanium system compatible with other titanium implants; Stainless steel system compatible with other stainless steel implants.	Met: "The titanium system is compatible with other medical grade implants made of titanium and the stainless steel system is compatible with other stainless steel implants..." (also stated in indications).

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

Not applicable. No clinical test set was used. The "test set" was entirely non-clinical laboratory testing. The submission does not specify the sample size or details of the non-clinical tests performed.

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

Not applicable. No clinical test set or human-established ground truth was used in this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for bone fixation, not an AI or imaging diagnostic device. No MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was effectively:

The established performance and safety profiles of the cited predicate devices (Medtronic/Sofamor Danek Atlas™ Cable System, K920201, K925812, K030816; Songer Spinal Cable System, K922952).
The results of non-clinical laboratory testing which "indicated that the device was functional within its intended use."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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OCT 2 3 2007

510(k) Summary

Preparation Date:	October 17, 2007
Applicant/Sponsor:	Biomet Spine (aka EBI, names may be used interchangeably)100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Becky Earl/Debra L. Bing
Proprietary Name:	Biomet® Cable System
Common Name:	Cable System
Classification Name:	Cerclage, Bone Fixation (CFR 888.3010)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Medtronic/Sofamor Danek Atlas™ Cable System, K920201, K925812, K030816; Songer Spinal Cable System, K922952.

Device Description: The Biomet® Cable System is available in either titanium or stainless steel, consisting of a flexible, multi-strand, medical grade titanium alloy (Ti-6Al-4V, ASTM F-136) or a medical grade stainless steel (316LVM, ASTM F-138) cable. The systems are available in both single and double styles. The cable is locked into place via a pre-loaded crimp. Instruments for the Biomet® Cable System include a Cable Tensioner, a Cable Crimper, and a Cable Cutter. The titanium system is compatible with other medical grade implants made of titanium and the stainless steel system is compatible with other stainless steel implants, whenever "wiring" may help secure the attachment of other implants.

Indications for Use: The Biomet® Cable System is indicated for use whenever a conservative or nonimplant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated.

1. Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants.
1. Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty.
1. Sternotomy indications include the "re-wiring" of sternums following osteotomy.
1. Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.

Summary of Technologies:

The technological characteristics (materials, design, sizing, indications) of the Biomet® Cable System are similar or identical to the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc., except for Atlas™, which belongs to Medtronic/Sofamor Danek

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, with three wavy lines representing the body and a stylized head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2007

Biomet Manufacturing Corp % Ms. Becky Earl Regulatory Specialist P. O. Box 587 Warsaw, IN 46581

Re: K071271

Trade/Device Name: Biomet® Cable Ssystem Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: October 17, 2007 Received: October 18, 2007

Dear Ms. Earl:

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 -- Ms. Becky Earl

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 the reporting 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 A. Milliken

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): ______________

Device Name: Biomet® Cable System

Indications for Use: The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated.

1. Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants.
1. Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty.
1. Sternotomy indications include the "re-wiring" of sternums following osteotomy.
1. Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (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)

[signature]

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K07127

Page 1 of 1

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.