When intended to promote fusion of the cervical spine and occipito-cervico-thoracic iunction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal Svstem is intended for:

. DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
spondylolisthesis .
. spinal stenosis
fracture/dislocation .
atlanto/axial fracture with instability ●
. occipitocervical dislocation
revision of previous cervical spine surgery .
. tumors

The occipital bone screws are limited to occipital fixation only.

The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.

The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Device Description

The MOUNTAINEER OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, lateral offset connectors, head-to-head connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws, monoaxial screws, hooks and SONGER® Cables.

The MOUNTAINEER OCT System Titanium Rods (Ti-6AL-4V) are offered in both Straight and Dual Diameter designs. The Straight Rod diameter is 3.5mm and has lengths ranging from 25mm-100mm in increments of 5mm and lengths ranging from 100mm-400mm in increments of 20mm. The Dual Diameter Rods consists of 3.5 - 4.5mm, 3.5 -4.75mm. 3.5 - 5.5mm. and 3.5 - 6.35mm diameters with Rod lengths of 420mm and 600mm.

The proposed MOUNTAINEER Cobalt Chromium (Co-Cr) Rods also consist of both Straight and Dual Diameter designs. The Straight Rod diameter is 3.5mm and available in lengths ranging from 25mm to 100mm (increments of 5mm) and 120, 200, 340 and 400mm. The Dual Diameter MOUNTAINEER Co-Cr Rods consist of 3.5 – 4.5mm, 3.5 – 4.75mm, 3.5 – 5.5mm and 3.5 – 6.35mm and available in lengths of 420 and 600mm.

Other than the modifications to the material from Ti-6Al-4V to Co-Cr, no other modifications have been made. The proposed Cobalt Chromium rods are not being made to address a known recall or adverse events. These proposed components have been developed as additions to the existing MOUNTAINEER OCT Spinal System.

AI/ML Overview

The MOUNTAINEER OCT Spinal System is not an AI/ML powered medical device. The information provided describes a traditional medical device (Spinal System) and its 510(k) submission. Therefore, it does not have the acceptance criteria or study details typically associated with AI/ML device performance.

The submission focuses on demonstrating substantial equivalence to a predicate device based on material change (from Titanium to Cobalt Chromium) while maintaining identical design, indications for use, and technology.

Here's an analysis based on the provided text, focusing on the available "Performance Data" which is relevant to a non-AI device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are tied to mechanical performance standards to ensure the new material (Cobalt Chromium) performs equivalently to the predicate Titanium device. The reported performance refers to the results of these tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Equivalence to Predicate Device:
Static Compression-Bending strength (per ASTM F 1717)	(Not explicitly stated in numerical terms in the summary, but the conclusion states that performance testing demonstrates that the device is as safe, as effective, and performs as well as the predicate device. This implies the new material met or exceeded the predicate's performance in these tests.)
Dynamic Compression-Bending (Fatigue) strength (per ASTM F 1717)	(Not explicitly stated in numerical terms in the summary, but the conclusion states that performance testing demonstrates that the device is as safe, as effective, and performs as well as the predicate device. This implies the new material met or exceeded the predicate's performance in these tests.)
Static Torsion strength (per ASTM F 1717)	(Not explicitly stated in numerical terms in the summary, but the conclusion states that performance testing demonstrates that the device is as safe, as effective, and performs as well as the predicate device. This implies the new material met or exceeded the predicate's performance in these tests.)
Compliance with ASTM F 1717:	Performance data per ASTM F 1717 were submitted to characterize the subject MOUNTAINEER OCT Spinal System rods addressed in this notification. This indicates that the testing methodology aligned with the standard, and the results were deemed acceptable for regulatory clearance.
Overall Safety and Effectiveness Equivalence:	Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device. This is the ultimate acceptance criterion for this type of 510(k) submission, confirming that the new Cobalt Chromium rods meet the required performance standards.

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

Sample Size: Not explicitly stated in the provided text. Mechanical testing typically involves a sufficient number of samples to achieve statistical significance for each test (static, dynamic, torsion).
Data Provenance: The data is from "Performance data per ASTM F 1717" submitted by the manufacturer, DePuy Spine, Inc. This is prospective testing of the device itself, not retrospective patient data.

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

Not applicable. For a mechanical device, performance is established through objective, standardized physical testing (e.g., ASTM F 1717), not through expert consensus on medical images or patient outcomes. The "ground truth" is the physical properties and performance of the device under specific load conditions.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical data, especially in studies involving AI/ML where ground truth needs to be established from subjective interpretations. This submission involves objective mechanical testing.

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

Not applicable. This is not an AI/ML powered device, and no MRMC study was conducted or is relevant for this type of device submission.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F 1717). The measured physical properties and performance characteristics (e.g., strength, fatigue resistance) of the Cobalt Chromium rods, when compared against the established performance of the Titanium predicate device, serve as the ground truth for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

Not applicable. This is not an AI/ML powered device.

Summary

{0}------------------------------------------------

510(K) SUMMARY

A.	Submitter Information
		DePuy Spine, Inc.
		325 Paramount Drive
		Raynham, MA 02767
	Contact Person:	Luke Bulino
		Senior Regulatory Affairs Associate
	Voice:	(508) 828-3267
	Fax:	(508) 828-3797
	E-Mail:	lbulino1@its.jnj.com
B.	Date Prepared	2/04/11
C.	Device Name
	Trade/Proprietary Name:	MOUNTAINEER OCT Spinal System
	Common/Usual Name:	Spinal System
	Classification Name:	Spinal interlaminar fixation orthosisper 21 CFR §888.3050

D. Predicate Device Name

Trade names: DePuy MOUNTAINEER OCT Spinal System (K042508, K080828)

E. Device Description

The MOUNTAINEER OCT System Titanium Rods (Ti-6AL-4V) are offered in both Straight and Dual Diameter designs. The Straight Rod diameter is 3.5mm and has lengths

{1}------------------------------------------------

ranging from 25mm-100mm in increments of 5mm and lengths ranging from 100mm-400mm in increments of 20mm. The Dual Diameter Rods consists of 3.5 - 4.5mm, 3.5 -4.75mm. 3.5 - 5.5mm. and 3.5 - 6.35mm diameters with Rod lengths of 420mm and 600mm.

F. Intended Use

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic iunction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal Svstem is intended for:

. DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
spondylolisthesis .
. spinal stenosis
fracture/dislocation .
atlanto/axial fracture with instability ●
. occipitocervical dislocation
revision of previous cervical spine surgery .
. tumors

The occipital bone screws are limited to occipital fixation only.

The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.

{2}------------------------------------------------

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

The proposed devices are identical to the predicate device with the exception of the material being changed from Titanium to Cobalt Chromium. The design, indications for use, and technology remain identical to the predicate system.

G. Materials

Manufactured from ASTM F-1537 Cobalt Chromium.

H. Performance Data

Performance data per ASTM F 1717 were submitted to characterize the subject MOUNTAINEER OCT Spinal System rods addressed in this notification. This testing was compromised of static and fatigue testing on the proposed device. Specifically, static and dynamic compressionbending testing as well as static torsion testing was performed.

l. Conclusion

Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized depiction of an eagle with its wings spread, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DePuy Spine, Inc. % Mr. Christopher Rogers 325 Paramount Drive Raynham, Massachusetts 02767

Re: K110353

Trade/Device Name: Mountaineer OCT Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: K WP Dated: March 11, 2011 Received: March 14, 2011

APR - 7 2011

Dear Mr. Rogers:

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. Ilsting 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

{4}------------------------------------------------

Page 2 - Mr. Christopher Rogers

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.

Kry B. R. h
fr.

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

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Unknown

MOUNTAINEER OCT Spinal System Device Name:

Indications For Use:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by . patient history and radiographic studies)
. spondylolisthesis
. spinal stenosis
. fracture/dislocation
. atlanto/axial fracture with instability
occipitocervical dislocation .
revision of previous cervical spine surgery .
� tumors

The occipital bone screws are limited to occipital fixation only.

The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Offig of Device Evaluation (ODE)

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

KI10353 510(k) Number_

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.