The Universal Clamp Spinal Fixation System 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. The indications for use include 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 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions.

The Universal Clamp System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Device Description

The Universal Clamp Spinal Fixation System consists of a woven band with a stiff guiding section at one end and metal buckles at the other end, implantable grade metal clamps that mate with 4.5mm - 6.35mm diameter rods, and an implantable grade metal locking screw that tightens the clamp over the band securing it to the connecting rod.

Implants made from implantable grade titanium, implantable grade titanium alloy, and implantable grade cobalt chromium may be used together. Due to the risk of galvanic corrosion, never use titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.

AI/ML Overview

This document is a 510(k) premarket notification for the Universal Clamp Spinal Fixation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Performance in accordance with ASTM F1798	All performance testing passed the acceptance criteria.
Performance as well as predicate systems	Demonstrated performance as well as or better than the predicate systems.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly states that "Performance testing (static axial pushdown, static axial rotation, static axial tension, and dynamic tension) was conducted to in accordance with ASTM F1798."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a spinal fixation system, and its performance is evaluated through mechanical testing, not through expert-reviewed diagnostic image interpretation or similar processes that would require establishing a ground truth based on expert consensus.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments, not for mechanical performance testing of an implantable device.

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

An MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool or an imaging device directly involving human readers.

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

This information is not applicable. The device is a mechanical implant, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The type of ground truth used

The ground truth for evaluating the device's performance was established through mechanical testing standards, specifically ASTM F1798. This standard likely defines specific parameters, test methods, and pass/fail criteria for spinal fixation systems.

8. The sample size for the training set

This information is not applicable. The Universal Clamp Spinal Fixation System is a mechanical implant, not a machine learning or AI-based device that would require a training set.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this type of device.

Summary

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

October 29, 2014

Zimmer Spine, Incorporated Ms. Holly Seppanen Regulatory Affairs Project Manager 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K142053

Trade/Device Name: Universal Clamp Spinal Fixation System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: August 7, 2014 Received: August 8, 2014

Dear Ms. Seppanen:

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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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Ronald P. Dean -S for

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

Enclosure

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Indications for Use

510(k) Number (if known) K142053

Device Name

Universal Clamp Spinal Fixation System

Indications for Use (Describe)

The Universal Clamp Spinal Fixation System 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. The indications for use include 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 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions.

The Universal Clamp System may also be used in conjunction with other medical grade implants metals whenever "wiring" may help secure the attachment of the other implants.

Type of Use (Select one or both, as applicable)
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2 Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

Universal Clamp® Spinal Fixation System

Date of Summary Preparation:	October 21, 2014
Company:	Zimmer Spine, Inc.Cité Mondiale23, Parvis des Chartrons33080 Bordeaux, France
Establishment Registration Number:	3003853072
Company Contact:	Holly SeppanenRegulatory Affairs Project ManagerEmail: Holly.Seppanen@zimmer.comOffice: 952.830.6240
Trade Name(s):	Universal Clamp Spinal Fixation System
Device Name (Common Name):	Spinal Fixation System
Device Classification:	Class II
Regulation Number andProduct Code(s):	21 CFR § 888.3010 / OWI
Regulation Name:	Bone fixation cerclage
Predicate(s):	Zimmer Spine Universal Clamp Spinal FixationSystem (K110348*, K091190, S€1 FÎ GGÊK060009)Spinal Concepts CFIX Cable System(K974020)
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General Device Description:

lmplants made from implantable grade titanium, implantable grade titanium alloy, and implantable grade cobalt chromium may be used together. Due to the risk of galvanic corrosion, never use titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.

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Indications for Use:

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 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions.

The Universal Clamp System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Summary of Performance Testing:

Performance testing (static axial pushdown, static axial rotation, static axial tension, and dynamic tension) was conducted to in accordance with ASTM F1798. All performance testing passed the acceptance criteria and demonstrated the device performed as well or better than the predicate systems.

Substantial Equivalence:

The subject Zimmer Spine Universal Clamp Spinal Fixation System configurations are similar to predicate devices with respect to intended use, mechanical and functional performance and technological characteristics. The information contained in this submission show that the subject Universal Clamp Spinal Fixation System is substantially equivalent to the predicate devices.

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.