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 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, Matrix or MIRS 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 the Matrix System or MIRS.

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.

Device Description

Synthes MIRS is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium). This system is comprised of polyaxial reduction screws, rods, and locking caps. This system is intended to facilitate minimally invasive spinal reduction. The components of this system are manufactured of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05), Titanium (Ti-4 per ASTM F67-06) and cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Synthes MIRS device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria (Implied)	Reported Device Performance
Static Compression Bending	Equivalent or superior to predicate devices (ASTM F1717-10)	Performs equivalently or superiorly to the above-mentioned predicates
Static Torsion	Equivalent or superior to predicate devices (ASTM F1717-10)	Performs equivalently or superiorly to the above-mentioned predicates
Dynamic Compression Bending	Equivalent or superior to predicate devices (ASTM F1717-10)	Performs equivalently or superiorly to the above-mentioned predicates

Note on Acceptance Criteria: The document directly states that the device "performs equivalently or superiorly to the above-mentioned predicates" for each test. This implies that the acceptance criteria were defined as achieving at least equivalence to the performance of the specified predicate devices when tested according to ASTM F1717-10.

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

This information is not provided in the given 510(k) summary. The document focuses on bench testing, not clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the study was non-clinical bench testing. There was no ground truth based on expert clinical assessment.

4. Adjudication Method for the Test Set

This information is not applicable as the study was non-clinical bench testing. There was no clinical ground truth requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical data and conclusions were not needed for this device."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to this device. The Synthes MIRS is a pedicle screw spinal system, a physical medical device, not a software algorithm that performs diagnostic or assistive tasks.

7. Type of Ground Truth Used

The "ground truth" for this non-clinical study was the bench testing standards (ASTM F1717-10) and the performance of legally marketed predicate devices. The goal was to demonstrate mechanical equivalence or superiority.

8. Sample Size for the Training Set

This information is not applicable as the study was non-clinical bench testing. There was no "training set" in the context of an algorithm or machine learning.

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

This information is not applicable as the study was non-clinical bench testing.

Summary

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长川 3044 DEC 2 1 2011

@ SYNTHES® Spine

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
Date Prepared:	December 6, 2011
Trade Name:	Synthes MIRS
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 and Polyaxial, K082572Synthes Matrix System, K092929Synthes Matrix System, K093668Synthes Matrix System, K100952Synthes Matrix System, K100634Synthes 6.0 CoCr and CP Ti-3 Rods, K103287DePuy Viper 2, K090648Abbott Spine Pathfinder, K030625Abbott Spine Pathfinder, K071174DePuy Expedium, K041119Medtronic CD Horizon, K111457
Device Description:	Synthes MIRS is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium). This system is comprised of polyaxial reduction screws, rods, and locking caps. This system is intended to facilitate minimally invasive spinal reduction. The components of this system are manufactured of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05), Titanium (Ti-4 per ASTM F67-06) and cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).
Intended Use/ Indications for Use:	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
510(k) Summary
curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann'sDisease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transversebars 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 USS6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. Inaddition, when used with 3.5 mm/5.0mm parallel connectors, the SynthesSmall Stature USS can be linked to the CerviFix 3.5mm Systems. Whenused with the 5.0 mm/6.0mm parallel connectors, the Synthes Small StatureUSS can be linked to the Synthes USS 6.0 mm rod systems.
When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, theSynthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mmand 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5mm and4.0 mm/5.5 mm tapered rods, Matrix or MIRS can be linked to the CerviFix3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can belinked to the Matrix System or MIRS.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with allUSS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only beused with Pangea.
Synthes USS6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening,USS VAS variable axis components, USS Fracture, Click'X, Click'XMonoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USSIliosacral, 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 MIRS 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 MIRS performs equivalentlyor superiorly to the above-mentioned predicates in static compressionbending, static torsion, and dynamic compression bending (in accordancewith ASTM F1717-10).Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.

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® SYNTHES®

Spine

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes extending from its body, representing the department's commitment to health, human services, and the pursuit of well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.

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

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

DEC 2 1 2011

Re: K113044

Trade/Device Name: Synthes MIRS Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWQ, KWP Dated: December 06, 2011 Received: December 07, 2011

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

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Page 2 - Ms. Heather Guerin

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 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,
for

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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Image /page/4/Picture/0 description: The image shows the logo for SYNTHES Spine. The logo consists of the SYNTHES name in bold, black letters, with a registered trademark symbol after the S. Below the name is the word "Spine" in a smaller, non-bold font.

Indications for Use Statement

510(k) Number: _K113044 Device Name: Synthes MIRS

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, Schevermann's Disease), turnor, 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.

Synthes USS

6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis o components, USS Fracture, Click'X, 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 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)

(Division Sign-Off) Division of Surgical, Orthopedic, 52 and Restorative Devices

K113044 Response to Al Synthes MIRS Traditional 510(k)

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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.