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

Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.

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

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

Device Description

This is an addition to Synthes' existing non-cervical spinal fixation devices intended for 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). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The additional locking cap in this submission is manufactured of cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).

AI/ML Overview

The provided text describes a 510(k) Summary for a medical device called the "Synthes Matrix System," which is an addition to an existing line of non-cervical spinal fixation devices. The document explicitly states that clinical data and conclusions were NOT needed for this device. This means that the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not available in this document because a clinical study was not performed or deemed necessary for this 510(k) submission.

The acceptance criteria and proof of meeting them are based on non-clinical performance data (bench testing), which demonstrated equivalence or superiority to predicate devices.

Here's a breakdown of the available information:

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

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence or superiority to predicate devices in mechanical properties	Bench testing results demonstrate that Synthes Matrix performs equivalently or superiorly to the above-mentioned predicates in static compression bending, static torsion, and dynamic compression bending (in accordance with ASTM F1717-11a).
Compliance with relevant ASTM standards	The testing was conducted in accordance with ASTM F1717-11a (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (for Posterior Spinal Implant Constructs)).

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

Sample Size for Test Set: Not specified. (Refers to mechanical testing specimens, not human subjects or a data set for an AI model).
Data Provenance: Not applicable in the context of human data. The data comes from bench testing of the device components.

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

Experts: Not applicable. Ground truth for mechanical testing is established by engineering specifications and direct measurement, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Adjudication Method: Not applicable. This is mechanical bench testing, not a clinical study requiring adjudication of diagnostic outcomes.

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

MRMC Study: No. This device is a spinal implant, not an AI or diagnostic imaging device. No human reader studies were performed or relevant.

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

Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm or AI.

7. The type of ground truth used

Ground Truth: For mechanical testing, the ground truth is based on the physical properties and performance characteristics defined by engineering standards (e.g., ASTM F1717-11a) and compared against the performance of legally marketed predicate devices.

8. The sample size for the training set

Training Set Sample Size: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

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

Ground Truth for Training Set: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

In summary, this 510(k) submission relied on non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices, and explicitly stated that clinical data was not required. Therefore, all questions pertaining to clinical study design, human data, expert review, and AI model specifics are not addressed by the provided document.

Summary

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510(k) Summary

510(k) Summary
Name of Firm:	Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380
510(k)Contact:	Heather GuerinSenior Regulatory Affairs SpecialistTelephone: 610-719-5432Facsimile: 610-719-5102Email: guerin.heather@synthes.com
DatePrepared:	June 28, 2012
Trade Name:	Synthes Matrix System
Classification:	21 CFR 888.3070 -Pedicle screw spinal systemClass IIIOrthopaedic and Rehabilitation Devices PanelProduct Code: NKB, MNH, MNI, KWQ, KWP
Predicates:	Synthes USS, K963045Synthes Click'X, K992739Synthes Click'X, K031175Synthes USS Illiosacral andPolyaxial, K082572Synthes Matrix System, K092929Synthes Matrix System, K093668Synthes Matrix System, K100952Synthes Matrix System, K100634	Medtronic CD Horizon, K113529EBI/Biomet Polaris, K111957Aesculap S4, K112551Synthes USS, K111358Synthes MIRS, K113044Synthes USS, K113149
DeviceDescription:	This is an addition to Synthes' existing non-cervical spinal fixation devices intended for 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). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The additional locking cap in this submission is manufactured of cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).
Intended Use/Indications forUse:	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
510(k) Summary
	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 posteriorpedicle screw construct.
	When used with the 3.5 mm/6.0mm parallel connectors, the SynthesUSS 6.0 mm rod systems can be linked to the CerviFix 3.5mmSystems. In addition, when used with 3.5 mm/5.0mm parallelconnectors, the Synthes Small Stature USS can be linked to theCerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mmparallel connectors, the Synthes Small Stature USS can be linked tothe Synthes USS 6.0 mm rod systems. When used with the 5.5mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mmrod systems can be linked to the Synthes USS 6.0 mm rod systems.5.5 mm/5.5mm parallel or extension connectors can be used to linkall Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mmparallel or extension connectors can be used to link all Synthes USS6.0 mm rod systems to one another.
	Rod-to-rod connectors can be used to link all Synthes USS 5.5 mmrod systems to one another.
	When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm taperedrods, the Synthes USS 6.0 mm rod systems can be linked to theCerviFix 3.5 mm and 4.0 mm Systems, respectively. When used withthe 3.5 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Synthes USS5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0mm Systems, respectively. When used with the 5.5 mm/6.0mmtapered rods, the Synthes USS 6.0 mm rod systems can be linked toSynthes USS 5.5 mm rod systems.
	In addition, Synthes USS 6.0 mm rod systems can be interchangedwith 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. Synthes USS 5.5 mm rodsystems can be interchanged with all USS 5.5 mm rods andtransconnectors.
	Synthes USS6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening,●USS VAS variable axis components. USS Fracture, Click'X
-510(k) Summary	Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial,USS Iliosacral, ClampFix 5.5 mm Rod System: Matrix, MIRS 5.0 mm Rod System: USS Small Stature CerviFix 3.5 mm Rod Systems: CerviFix, Axon, Synapse 4.0 mm Rod System: Synapse
Comparison ofthe device topredicatedevice(s):	Synthes Matrix is substantially equivalent to the above-mentionedpredicates in design, function, material and intended use.
PerformanceData(Non-Clinicaland/orClinical):	Non-Clinical Performance and Conclusions:Bench testing results demonstrate that Synthes Matrix performsequivalently or superiorly to the above-mentioned predicates in staticcompression bending, static torsion, and dynamic compressionbending (in accordance with ASTM F1717-11a).Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with its wings forming a curved shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

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

Synthes Spine % Heather Guerin, Ph.D. Senior Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K120838

Trade/Device Name: Synthes Matrix System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWQ, KWP Dated: June 28, 2012 Received: June 29, 2012

JUL 3 1 2012

Dear Dr. 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 r lease oe action and a determination that your device complies with other requirements of the Act that 127 has intact a coulations administered by other Federal agencies. You must or uny rederal bakated and surveyed to the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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

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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Indications for Use Statement

510(k) Number: K120838 Synthes Matrix System Device Name:

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 adiunct 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, 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 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5:0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.

Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Beethold formKM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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Synthes USS

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

CerviFix

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

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Seelhold for MXM
(Division Sign-Off)

Division at surgical. Orthopedic, and Restorative Devices

510(k) Number K120838

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.