When intended to provide stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon; OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft and/or autograft for the following:

Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc as confirmed by patient history and radiographic studies)
. Spondylolisthesis
Spinal stenosis .
Fracture/dislocation .
Atlantoaxial fracture with instability .
Occipitocervical dislocation .
Revision of previous cervical spine surgery .
Tumor .

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars

The rods, clamps, screws, nuts, variable axis screws, locking screws and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (TI-T3).

The use of these screws (3.5 mm. 4.0 mm and 4.5 mm cancellous and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm paralle1 connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks; 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.

Device Description

The Synapse System is a hook and pedicle screw spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and Cervifix System also included in the indications for use statement are additional hook and pedicle screw spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks: interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors. These system components are implanted using class I surgical instruments.

AI/ML Overview

This document describes a 510(k) premarket notification for the Synapse System, specifically focusing on proposed curved rods. It is a submission intended to demonstrate substantial equivalence to previously cleared devices, rather than a study proving performance against acceptance criteria for a novel device.

Therefore, many of the requested categories for a study proving device performance are not applicable (N/A) in this context, as this submission primarily relies on a "rationale" comparing the new components to existing ones, rather than new performance testing.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Conformance: Curved rods manufactured from Ti-6A1-7Nb (TAN), conforming to ASTM F-1295-11 and ISO 5832-11.	The proposed curved rods are manufactured from the same material, titanium aluminum niobium (Ti-6A1-7Nb (TAN)), as the previously cleared Synapse System curved rods. The material conforms to ASTM F-1295-11 and ISO 5832-11.
Technological Characteristics: Indications for use, intended use, and technological characteristics (design, material) of proposed curved rods are the same as, or similar to, predicate devices.	The indications for use, intended use and technological characteristics, such as design and material, of the proposed curved rods are the same as, or similar to, those of the predicate devices from the Synapse System, Sierra™ System and Altius™ OCT System.
Performance Testing: (Implied: No new performance testing required if substantial equivalence is based on existing data/rationale).	A rationale is provided in place of performance testing for the proposed curved rods. (This indicates that the "performance criteria" were met by demonstrating equivalence rather than actual new testing.)

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

Sample Size: N/A. No new test set involving patient data or specimens was described. The submission relies on a "rationale" for equivalence to predicate devices.
Data Provenance: N/A. No new data from a test set (e.g., country of origin, retrospective/prospective) is presented. The "performance data" section explicitly states "A rationale is provided in place of performance testing."

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

N/A. As no new test set data requiring ground truth establishment was presented, this is not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. No test set requiring expert adjudication was described.

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

N/A. This device is a spinal fixation orthosis (physical implant system), not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

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

N/A. This is a physical implant, not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A. No new ground truth establishment was described, as the submission focused on comparing the new components to established predicate devices based on design, materials, and existing performance data (implied from the predicates).

8. The sample size for the training set

N/A. No training set for an algorithm was involved; this is a physical medical device.

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

N/A. No training set or associated ground truth was established for this submission.

Summary of the Submission's Approach:

The K133698 submission for the Synapse System (specifically, proposed curved rods) is a substantial equivalence (SE) submission. This means the applicant demonstrated that the new device components (curved rods) are as safe and effective as a legally marketed predicate device.

Instead of conducting new performance studies, the manufacturer provided a "rationale" arguing that:

The materials (Ti-6A1-7Nb (TAN)) are identical to those used in previously cleared components.
The technological characteristics (design, intended use, indications for use) of the proposed curved rods are the same or similar to predicate devices (Synapse System, Sierra™ System, Altius™ OCT System).

This approach is common in 510(k) submissions where modifications to existing devices are minor and do not raise new questions of safety or effectiveness. The FDA's clearance (as indicated in the letter dated January 16, 2014) confirms their agreement that the device is substantially equivalent to predicates.

Summary

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K133698 Page 1 of 4

510(K) SUMMARY

JAN 1 6 2014

Submitter Information A.

Submitter:

Synthes USA Products LLC 1302 Wrights Lane East West Chester, Pennsylvania 19380

Contact Person:

Telephone number: Fax number: Email:

Laura Bleyendaal DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 (508) 828-3267 (508) 828-3797 LBleyend@its.jnj.com

B. Date Prepared January 15, 2014

C. Device Name

Trade/Proprietary Name: Common/Usual Name:

Synapse System Spinal interlaminal fixation orthosis

Class II, per 21 CFR §888.3050

Subsequent Regulation:

Device Classification

and Regulation:

21 CFR §888.3070

Classification Product and Panel Code:

KWP; Orthopedic

Subsequent Product and Panel Codes:

MNI; Orthopedic MNH; Orthopedic

D. Predicate Device Name

Synthes Synapse System (most recently cleared K091689) Trade name: Sierra™ System (K062934, K080526)

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Altius™ OCT System (K033961, K043229)

E. Device Description

Indications for Use F.

These Systems are intended for the following:

Hooks, Plate/Rods, Plates, Rods and Screws

Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc as confirmed by patient history and radiographic studies)
. Spondylolisthesis
Spinal stenosis .
Fracture/dislocation .
Atlantoaxial fracture with instability .
Occipitocervical dislocation .
Revision of previous cervical spine surgery .
Tumor .

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

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Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.

G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use

The indications for use, intended use and technological characteristics, such as design and material, of the proposed curved rods are the same as, or similar to, those of the predicate devices from the Synapse System, Sierra™ System and Altius™ OCT System.

H. Materials

The proposed curved rods are manufactured from the same material, titanium aluminum niobium (Ti-6A1-7Nb (TAN)), as the previously cleared Synapse System curved rods. The material conforms to ASTM F-1295-11 Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications and ISO 5832-11 Implants for surgery- Metallic materials-Part 11: Wrought titanium 6-aluminum 7niobium alloy.

【. Performance Data

A rationale is provided in place of performance testing for the proposed curved rods.

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J. Conclusion

The substantial equivalence justification demonstrates that the proposed curved rods are substantially equivalent to the predicate devices in the Synapse System, the Sierra™ System and the Altius™ OCT System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, with three curved lines forming the body and head.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G608 Silver Spring, MD 20993-0002

January 16, 2014

Synthes USA Products, LLC Ms. Laura Blevendaal Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K133698

Trade/Device Name: Synapse System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: December 20, 2013 Received: December 23, 2013

Dear Ms. Bieyendaal:

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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Page 2 - Ms. Laura Bleyendaal

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wigqins

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 STATEMENT

510(k) Number (if known): K133698

Device Name: Synapse System

Indications For Use:

These Systems are intended for the following:

Hooks, Plate/Rods, Plates, Rods and Screws

When intended to provide stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon, OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft and/or autograft for the following:

Degenerative Disc Disease (DDD) (defined as neck pain of discogenic . origin with degeneration of the disc as confirmed by patient history and radiographic studies)
Spondylolisthesis .
Spinal stenosis .
Fracture/dislocation .
Atlantoaxial fracture with instability .
Occipitocervical dislocation .
Revision of previous cervical spine surgery .
Tumor .

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars

The use of these screws (3.5 mm, 4.0 mm and 4.5 mm cancellous and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

{7}------------------------------------------------

The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Zane W. Witte S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133698

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.