The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm extension connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm extension connectors can be used to link all Synthes USS 6.0mm rod systems to one another.

When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.

In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.

Device Description

The Synthes USS Line Extension is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are in-line extension connectors which can connect spinal rods of the same or different diameters. The in-line extension connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).

AI/ML Overview

The document describes the K113149 510(k) submission for the Synthes USS Line Extension (connectors), which are non-cervical spinal fixation devices.

Here's an analysis of the provided text with respect to your questions:

1. Table of acceptance criteria and the reported device performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Static Compression Bending	Substantially equivalent to predicate devices (Synthes USS, K962608; Synthes USS, K963045; Synthes Click'X, K992739; Synthes Click'X, K031175; Synthes USS Illiosacral and Polyaxial, K082572; Synthes Matrix System, K092929; Synthes Matrix System, K100634; Synthes Matrix System, K100952; Synthes 6.0 CoCr and CP Ti-3 Rods, K103287)	The testing determined that the Synthes USS Connector is substantially equivalent to the predicate devices.
Static Torsion	Substantially equivalent to predicate devices	The testing determined that the Synthes USS Connector is substantially equivalent to the predicate devices.
Dynamic Compression Bending	Substantially equivalent to predicate devices	The testing determined that the Synthes USS Connector is substantially equivalent to the predicate devices.

Explanation: The acceptance criteria are implicitly met if the "non-clinical testing according to ASTM F1717-10 - static compression bending, static torsion, and dynamic compression bending - to determine that the Synthes USS Connector is substantially equivalent to the predicate devices identified" was successful. The document states that the testing was conducted "to determine" this, and the FDA's clearance implies the substantial equivalence was demonstrated.

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

The document does not explicitly state the specific sample sizes (number of devices tested) for the non-clinical tests. It refers to "non-clinical testing according to ASTM F1717-10". ASTM F1717-10 is a standard for testing spinal implant constructs, and it would specify the required number of samples for each test type. The data provenance is non-clinical, meaning it's from laboratory testing rather than human subjects. The country of origin for the data is not specified, but the firm (Synthes Spine) is located in West Chester, PA, USA.

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

This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is based on the physical properties and performance measured against a standard (ASTM F1717-10), not on expert consensus or human interpretation.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert review of medical images or patient outcomes, not for mechanical bench testing.

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

This question is not applicable. MRMC studies are relevant for AI-powered diagnostic or interpretive devices that assist human readers (e.g., radiologists). This submission concerns a physical medical device (spinal connectors), not a diagnostic algorithm.

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

This question is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The ground truth used for these non-clinical tests is the performance metrics defined by the ASTM F1717-10 standard and the performance characteristics of the identified predicate devices. The new device's performance is compared against these established benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical bench testing for spinal implants. Training sets are relevant for machine learning or AI models.

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

This question is not applicable for the same reason as #8.

Summary

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® SYNTHES®
Spine

K113149

510(k) Summary

Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k) Contact:	Heather GuerinSpine Senior Regulatory Affairs SpecialistTelephone: 610-719-5432Facsimile: 610-719-5102Email: guerin.heather@synthes.com
Date Prepared:	December 30, 2011
Trade Name:Classification:	Synthes USS Line Extension21 CFR 888.3050-Spinal interlaminar fixation orthosis21 CFR 888.3060–Spinal intervertebral body fixation orthosis21 CFR 888.3070-Pedicle screw spinal system, Class IIIOrthopaedic and Rehabilitation Devices Panel
Predicates:	Product Code: NKB, MNH, MNI, KWQ, KWPSynthes USS, K962608Synthes USS, K963045Synthes Click'X, K992739Synthes Click'X, K031175Synthes USS Illiosacral and Polyaxial, K082572Synthes Matrix System, K092929Synthes Matrix System, K100634Synthes Matrix System, K100952Synthes 6.0 CoCr and CP Ti-3 Rods, K103287
DeviceDescription:	The Synthes USS Line Extension is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation(T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are in-line extension connectors which canconnect spinal rods of the same or different diameters. The in-lineextension connectors are comprised of TAN (Titanium-6 Aluminum-7Niobium, per ASTM F1295-05).
Intended Use/Indications forUse:	The Synthes USS are non-cervical spinal fixation devices intended forposterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited toskeletally mature patients with the exception of the Small Stature USS,which includes small stature and pediatric patients. These devices areindicated as an adjunct to fusion for all of the following indications:degenerative disc disease (defined as discogenic back pain withdegeneration of the disc confirmed by history and radiographic studies),spondylolisthesis, trauma ( i.e. , fracture or dislocation), deformities orcurvatures ( i.e. , scoliosis, kyphosis, and/or lordosis, Scheuermnann'sDisease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

510(k) SummaryWhen treating patients with Degenerative Disc Disease (DDD), transversebars are not cleared for use as part of the posterior pedicle screwconstruct.
When used with the 3.5/6.0mm parallel connectors, the Synthes USS6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. Inaddition, when used with 3.5/5.0mm parallel connectors, the SynthesSmall Stature USS can be linked to the CerviFix 3.5mm Systems. Whenused with the 5.0/6.0mm parallel connectors, the Synthes Small StatureUSS can be linked to the Synthes USS 6.0mm rod systems. When usedwith the 5.5/6.0mm extension connectors, Matrix can be linked to theSynthes USS 6.0mm rod systems. 6.0/6.0mm extension connectors canbe used to link all Synthes USS 6.0mm rod systems to one another.
When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the SynthesUSS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mmSystems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mmtapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mmSystems, respectively. When used with the 5.5/6.0mm tapered rods, theSynthes USS 6.0mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0mm rod systems can be interchanged with allUSS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only beused with Pangea.
Synthes USS6.0mm Rod Systems: USS Side-Opening, USS Dual-Opening,USS VAS variable axis components, USS Fracture, Click'X,Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial,USS Iliosacral, ClampFix 5.5mm Rod System: Matrix 5.0mm Rod System: USS Small Stature
CerviFix3.5mm Rod Systems: CerviFix, Axon, Synapse 4.0mm Rod System: Synapse
Comparison ofthe device topredicatedevice(s):PerformanceData(Non-Clinicaland/or Clinical):
The intended use, indications for use, and materials of manufacture of thesubject devices are the same as the predicate Synthes USS. The overalldesign and function of the predicate(s) are unaffected by the currentadditions.Synthes conducted non-clinical testing according to ASTM F1717-10 -static compression bending, static torsion, and dynamic compressionbending - to determine that the Synthes USS Connector is substantiallyequivalent to the predicate devices identified. Clinical data were not

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

FEB - 1 2012

Synthes Spine % Ms. Heather Guerin 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K113149

Trade/Device Name: Synthes USS Connectors Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: MNI, NKB, MNH, KWQ, KWP Dated: December 30, 2011 Received: January 03, 2012

Dear Ms. Guerin:

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

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Page 2 - Ms. Heather Guerin

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 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 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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,

incerely yours,

F.C

Nso Lin Dn
M. J. N. Mcllveen

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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@ SYNTHES Spine

Indications for Use Statement

510(k) Number: K113149 Device Name: Synthes USS Connectors

The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5), Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discognitude in pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous usion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

Synthes USS

6.0mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis . components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
5.5mm Rod System: Matrix .
- 5.0mm Rod System: USS Small Stature

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

CerviFix
8

3.5mm Rod Systems: CerviFix, Axon, Synapse .
. 4.0mm Rod System: Synapse

510(k) Number k11349

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.