SPINESMITH CYNCH SPINAL SYSTEM

• K Number: K090376
• Device Name: SPINESMITH CYNCH SPINAL SYSTEM
• Manufacturer: SPINE SMITH PARTNERS L.P.
• Date Cleared: 2009-04-01 ( 43 days)
• Product Code: MAX
• Regulation Number: 888.3080

Intended Use

The Cynch System is indicated 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

Cynch is curved to allow for medial-lateral placement of the device, and is available in two footprints (25mm and 30mm) with a 5° lordosis in various heights. Cynch is hollow to allow for the placement of autograft bone, and has large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.

Predicate Devices

P970015, P950002, P950019, P960025

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML device descriptions. The focus is on the mechanical design and intended use of a spinal fusion device.

Therapeutic

Yes
The device is an intervertebral body fusion device used to facilitate fusion in the lumbar spine for patients with degenerative disc disease. Its purpose is to treat a medical condition and restore function, qualifying it as a therapeutic device.

Diagnostic

No
The device, Cynch System, is an intervertebral body fusion device used for treatment of degenerative disc disease, facilitating fusion, and providing stability, rather than diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical implant (curved, available in footprints and heights, hollow, with teeth) intended for surgical implantation in the lumbar spine. This is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the Cynch System is for intervertebral body fusion of the lumbar spine. This is a surgical implant used in vivo (within the body) to facilitate bone fusion.
• Device Description: The description details a physical implant (curved, hollow, with teeth) designed to be placed within the spine.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze biological samples. The Cynch System is a surgical implant used in vivo.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Cynch System is indicated 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.

Product codes (comma separated list FDA assigned to the subject device)

MAX

Device Description

Cynch is curved to allow for medial-lateral placement of the device, and is available in two footprints (25mm and 30mm) with a 5° lordosis in various heights. Cynch is hollow to allow for the placement of autograft bone, and has large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar spine, from L2 to SI

Indicated Patient Age Range

skeletally mature patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Mechanical test results demonstrate that the Cynch System is substantially equivalent to the predicate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

P970015, P950002, P950019, P960025

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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K090376

SpineSmith Cynch Spinal System

APR - 1 2009

510(k) Summary of Safety and Effectiveness

SUBMITTED BY SpineSmith Partners, LP 8140 N. Mopac, Bldg II, Suite 120 Austin, TX 78759 ESTABLISHMENT 3006404071 REGISTRATION NUMBER CONTACT PERSON Robert Jones Vice President, Research and Development Phone: [phone] Fax: [phone] Email: [e-mail] SUBMISSION PREPARED BY Lisa Peterson Kaedon Consulting, LLC Phone: [phone] February 16, 2009 DATE PREPARED CLASSIFICATION MAX 888.3080- Intervertebral Fusion Device with Bone Graft, Lumbar COMMON NAME Intervertebral Body Fusion Device PROPRIETARY NAME SpineSmith Cynch Spinal System SUBSTANTIAL EQUIVALENCE The SpineSmith Cynch System was determined to be substantially equivalent to several recently down classified cages: -LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03) BAK® Cage (P950002, Zimmer Spine, Approved -7/8/03)

• RAY® Threaded Fusion Cage (P950019, Stryker, -Approved 9/4/03)
• Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) -

8140 N. Mopac, Bldg II, Suite 120 Austin, Texas 78759

SpineSmith Partners, LP

Phone: [phone] Fax: [phone]

1

K090376

DEVICE DESCRIPTION

Cynch is curved to allow for medial-lateral placement of the device, and is available in two footprints (25mm and 30mm) with a 5° lordosis in various heights. Cynch is hollow to allow for the placement of autograft bone, and has large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.

INDICATIONS:

The Cynch System is indicated 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.

MECHANICAL TEST DATA

Mechanical test results demonstrate that the Cynch System is substantially equivalent to the predicate.

8140 N. Mopac, Bldg II, Suite 120 Austin, Texas 78759

SpineSmith Partners, LP

Phone: [phone] Fax: [phone]

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized wings and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SpineSmith Partners, LP % Mr. Robert Jones Vice President, Research and Development 8140 N. Mopac, Building II, Suite 120 Austin. Texas 78759

APR - 1 2009

Re: K090376

Trade/Device Name: SpineSmith Cynch Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: February 16, 2009 Received: February 17, 2009

Dear Mr. Jones:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Paris 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Calben Buchen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K090376

Device Name:

SpineSmith Cynch Spinal System

Indications for Use:

The Cynch System is indicated 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.

Prescription Use X (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)
	(Division Sign-Off)
	Division of General, Restorative, and Neurological Devices

SpineSmith Partners, LP

| 8140 N. Mopac, Bldg II, Suite 120
Austin, Texas 78759 | Phone: [phone]
Fax: [phone] |

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