The CRESCENT™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

Device Description

The subject CRESCENT™ Spinal System consists of a variety of hollow intervertebral body spacers featuring a bullet-nosed, anatomically shaped design with axial voids designed to hold autogenous bone graft. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices are designed to be implanted through the transforaminal and direct lateral approaches. The devices range from 7mm to 15mm in height and from 25mm to 36mm in length. The devices are manufactured from Medical Grade PEEK (polyetheretherketone). These devices also contain Tantalum markers used for imaging purposes.

AI/ML Overview

The CRESCENT™ Spinal System is regulated as a Class II medical device (21 CFR 888.3080) with product code MAX. The provided text describes non-clinical tests conducted to demonstrate substantial equivalence to predicate devices, focusing on mechanical performance rather than clinical efficacy related to a device performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Method	Acceptance Criteria	Reported Device Performance
Static Axial Compression (ASTM 2077-03)	Demonstrated performance within acceptable limits or comparable to predicate devices in terms of load-bearing capacity and deformation. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance).	Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided).
Dynamic Axial Compression (ASTM 2077-03)	Demonstrated performance within acceptable limits or comparable to predicate devices under cyclic loading conditions for fatigue resistance. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance).	Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided).
Static Compression Shear (ASTM 2077-03)	Demonstrated performance within acceptable limits or comparable to predicate devices in resistance to shear forces. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance).	Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided).
Compression Shear Fatigue (ASTM 2077-03)	Demonstrated performance within acceptable limits or comparable to predicate devices under cyclic shear loading for fatigue resistance. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance).	Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided).
Subsidence Testing (ASTM F2267-04)	Demonstrated performance within acceptable limits or comparable to predicate devices in resistance to subsidence into vertebral endplates. (Specific quantitative criteria not provided in the text; implied to meet or exceed predicate device performance).	Results indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices. (Specific quantitative results are not provided).

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

Sample Size: The document does not specify the sample size for the mechanical tests. The tests refer to devices, but the number of devices tested for each condition is not stated.
Data Provenance: The data provenance is from non-clinical mechanical testing, performed in a laboratory setting. There is no mention of human or animal data.

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

This information is not applicable. The study described is a non-clinical mechanical test, not a study involving medical image analysis or expert review for ground truth establishment.

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

This information is not applicable. The study described is a non-clinical mechanical test, not a study involving expert adjudication.

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:

No. The provided text describes non-clinical mechanical tests for a spinal implant, not an MRMC comparative effectiveness study involving human readers and AI.

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

No. The provided text describes non-clinical mechanical tests for a spinal implant. There is no mention of an algorithm or AI performance.

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

The ground truth for the non-clinical tests was established by adherence to recognized ASTM standards (ASTM 2077-03 and ASTM F2267-04) and comparison to the mechanical performance of legally marketed predicate devices. The "ground truth" here is the established mechanical performance characteristics and safety profiles of existing, approved devices.

8. The sample size for the training set:

Not applicable. This is a non-clinical mechanical test report, not a study involving a training set for an algorithm.

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

Not applicable. This is a non-clinical mechanical test report, not a study involving a training set for an algorithm.

Summary

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CRESCENTTM Spinal System 510(k) Summary April 23, 2010

I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

APR 2 6 2010

Contact:	Jennifer Hackney
	Regulatory Affairs Specialist

Proprietary Trade Name: CRESCENT™ Spinal System II.

Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080) III.

IV. Product Code: MAX

V. Product Description

V. Indications

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VI. Identification of the Legally Marketed Predicate Devices Used to Claim Substantial Equivalence

Documentation was provided which demonstrated that the subject CRESCENT™ Spinal System is substantially equivalent to several interbody cages, including the CAPSTONE® Spinal System (K073291, SE 04/24/08), the LT-CAGE® PEEK Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), and the BRANTIGEN I/F CAGE® (DePuy, P960025), as well as to the VERTE-STACK® Spinal System (K052261, SE 10/07/05).

VII. Brief Discussion of the Non-Clinical Tests Submitted

The following mechanical tests of the subject CRESCENT™ Spinal System were performed :

. static axial compression testing in accordance with ASTM 2077-03:
dynamic axial compression testing in accordance with ASTM 2077-03; .
. static compression shear testing in accordance with ASTM 2077-03;
compression shear fatigue testing in accordance with ASTM 2077-03; and .
subsidence testing in accordance with ASTM F2267-04. .

VIII. Conclusions Drawn from the Non-Clinical Tests

Results of mechanical testing indicated that all acceptance criteria were met, demonstrating substantial equivalence to the listed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

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

Medtronic Sofamor Danek % Ms. Jennifer Hackney Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

APR 2 6 2010

Re: K094025

Trade/Device Name: CRESCENT™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 15, 2010 Received: April 16, 2010

Dear Ms. Hackney:

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

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Page 2 - Ms. Jennifer Hackney

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 n you don't oper.its aov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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 note the regardions 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 Tou may 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,

Barbara Buehrn

Mark N. Melke Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K094025

Device Name: CRESCENT™ Spinal System_

Indications for Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

ﺮ

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K094025

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.