The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Device Description

The SpineSmith Cynch System is offered in two (2) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach. The system consists of the Cynch TLIF device for transforaminal lumbar approach and the Cynch PLIF/T-PLIF device, which may be implanted via a posterior lumbar bi-lateral approach or transverse lumbar approach. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device.

The Cynch System implants are hollow to allow for the placement of autograft bone, and have large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the implants to provide increased stability and inhibit movement of the implant. The implants have horizontal grooves to locate the implant holder superior/inferior and rotationally. Additionally, a cross-bar is provided to minimize buckling during insertion.

AI/ML Overview

The provided document describes the SpineSmith Cynch Spinal System, an intervertebral body fusion device. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by Regulations/Standards)	Reported Device Performance (from Non-Clinical Testing)
Static Compression Performance (per ASTM F2077-03)	Substantially equivalent results to predicate devices
Dynamic Compression Performance (per ASTM F2077-03)	Substantially equivalent results to predicate devices
Subsidence Performance (per ASTM F2267-04)	Substantially equivalent results to predicate devices
Expulsion Performance (per ASTM Draft Standard F-04.25.02.02)	Substantially equivalent results to predicate devices

Explanation: The "acceptance criteria" here are defined by the referenced ASTM standards, which specify methods and requirements for evaluating the mechanical properties of intervertebral body fusion devices. The reported "device performance" indicates that the SpineSmith Cynch Spinal System achieved "substantially equivalent results" when tested according to these standards, meaning its mechanical performance was comparable to the predicate devices which have already been deemed safe and effective.

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

Sample Size: Not explicitly stated. The document mentions "non-clinical tests" and "results" but does not quantify the number of units tested for each mechanical assessment.
Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective). These are non-clinical mechanical tests conducted in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This is a mechanical device, and "ground truth" for its performance is established through adherence to standardized engineering tests (ASTM standards) rather than expert consensus on clinical interpretation or outcomes.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, the "test set" refers to mechanical properties evaluated against engineering standards. There is no human adjudication process involved in interpreting these test results beyond ensuring adherence to test protocols and data analysis.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a mechanical device, and an MRMC study is relevant for evaluating diagnostic or imaging devices where human readers interpret medical images. This document describes non-clinical mechanical tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

Engineering Standards and Predicate Device Performance: The "ground truth" for demonstrating the safety and effectiveness of the Cynch System is its ability to perform equivalently to predicate devices when subjected to established mechanical testing standards (ASTM F2077-03, ASTM F2267-04, ASTM Draft Standard F-04.25.02.02).

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no training set in this context.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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SpineSmith Cynch Spinal System

Kioloss
III - 1 2018

JUL - 1 2010

510(k) Summary of Safety and Effectiveness
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SUBMITTED BY	SpineSmith Partners, LP93 Red RiverAustin, TX 78701
ESTABLISHMENTREGISTRATION NUMBER	3006404071
CONTACT PERSON	Laura LeBoeufVice President - Quality and Regulatory AffairsPhone: 512-206-0770Fax: 512-637-6750Email: lleboeuf@spinesmithusa.com)
SUBMISSION PREPARED BY	Lisa PetersonKaedon Consulting, LLCPhone: 512-507-0746
DATE PREPARED	June 28, 2010
CLASSIFICATION	MAX 888.3080- Intervertebral Fusion Device with BoneGraft, Lumbar
COMMON NAME	Intervertebral Body Fusion Device
PROPRIETARY NAME	SpineSmith Cynch Spinal System

IDENTIFICATION OF PREDICATE DEVICES:

The SpineSmith Cynch System was determined to be substantially equivalent to the previously cleared Cynch System (K090376, SpineSmith; Cleared 2/16/2009) and the down classified Lumbar I/F cage (P960025, Depuy; Approved 3/4/2005).

DEVICE DESCRIPTION:

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INDICATIONS:

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The purpose of this submission is to add the Cynch PLIF/T-PLIF device, which may be implanted yia a posterior lumbar bi-lateral approach or transverse lumbar approach. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the subject device (Cynch PLIF / T-PLIF) has similar technological characteristics as the predicate devices identified above (SpineSmith's Cynch System per K090376, and Depuy's Lumbar I/F cage per P960025). Specifically, the following characteristics support this conclusion:

Intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis.
Hollow-body implant design to allow for placement of autograft bone -
-Implant material: PEEK Optima LT1 per ASTM F2026 with radiopaque tantalum markers per ASTM F-560-05
Substantially equivalent results of non-clinical testing relative to static and dynamic compression (per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

DISCUSSION OF NON-CLINICAL TESTING:

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with ASTM F2077-03 -
Subsidence testing, conducted in accordance with ASTM F2267-04 .
. Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02

CONCLUSIONS:

The subject and predicate devices share the same intended use, primary implant design and material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Cynch System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL - 1 2010

SpineSmith Partners, LP % Ms. Laura LeBoeuf 93 Red River Austin, Texas 78701

Re: K101085

Trade/Device Name: SpineSmith Cynch Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 08, 2010 Received: June 09, 2010

Dear Ms. LeBoeuf:

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. Laura LeBoeuf

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,

Barbara Spiehm

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

510(k) Number (if known):

Device Name: SpineSmith Cynch Spinal System

Indications for Use:

The Cynch System is indicated intervertebral body fusion of the fumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Oil) for Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101085

93 Red River Austin. Texas 78701 SpineSmith Partners, LP

Phone: 512-637-2068 Fax: 512-302-4920

لدا

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.