MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD by DEPUY ACROMED

The MONARCH Spine System when used with pedicle screws is indicated for degenerative spodylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The MONARCH Spine System when not used with pedicle screws is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion.

Device Description

The MONARCH Commercially Pure Titanium Spinal Rod is a 6.35mm diameter rod available in various lengths.

AI/ML Overview

The provided text describes a 510(k) submission for the MONARCH Spine System Commercially Pure Titanium Spinal Rod. This is a medical device submission, and the content focuses on establishing substantial equivalence to a predicate device, as required for 510(k) clearances. The text does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of AI/ML or diagnostic performance.

Instead, the "Performance Data" section merely states: "Performance data were submitted to characterize the MONARCH Commercially Pure Titanium Spinal Rod." This typically refers to mechanical, material, or biocompatibility testing required for a physical medical device, not a diagnostic or AI-driven system.

Therefore, I cannot fulfill your request for information related to acceptance criteria, device performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided document.

The document pertains to the regulatory clearance of a physical spinal rod, not an AI/ML diagnostic or predictive device.

Summary

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attained. Levels of attachment for this indication

range from L3 to the sacrum.

MAY 0 8 2002

IX. 510(k) Summary

SUBMITTER:

	325 Paramount DriveRaynham, MA 02767
CONTACT PERSON:	Lisa A. Gilman
DATE PREPARED:	March 29, 2002
	CLASSIFICATION NAME: Appliance, Fixation, Spinal InterlaminalOrthosis, Spinal Pedicle Fixation
PROPRIETARY NAME:	MONARCH SPINE SYSTEM COMMERCIALLYPURE TITANIUM SPINAL ROD
PREDICATE DEVICES:	MONARCH Spine System Spinal Rod (K010576)
DEVICE DESCRIPTION:	The MONARCH Commercially Pure Titanium SpinalRod is a 6.35mm diameter rod available in variouslengths.
INTENDED USE:	The MONARCH Spine System when used withpedicle screws is indicated for degenerativespodylolisthesis with objective evidence of neurologicimpairment, fracture, dislocation, scoliosis, kyphosis,spinal tumor, and failed previous fusion(pseudarthrosis). Levels of fixation are for thethoracic, lumbar and sacral spine.
	The MONARCH Spine System is also indicated forpedicle screw fixation for Grade 3 and 4spondylolisthesis at L5-S1, in skeletally maturepatients, utilizing autologous bone graft, having thedevice fixed or attached to the lumbar or sacral spineand intended to be removed after solid fusion is

DePuy AcroMed, Inc.

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1021148

MATERIALS:

Manufactured from Grade 3 commercially pure (cp) titanium conforming to ASTM F-67.

PERFORMANCE DATA:

Performance data were submitted to characterize the MONARCH Commercially Pure Titanium Spinal Rod.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 8 2002

Mr. Frank Maas Director, Regulatory Affairs DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K021148

Trade/Device Name: MONARCH Spinal System Commercially Pure Titanium Spinal Rod

Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: April 5, 2002 Received: April 10, 2002

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Frank Maas

This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in you of substantial equivalence of your device to a legally marketed nouticate 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 and 11 you desire specific arrivitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in The areguestions on the promotion and advertising of your device, (301) 594-1659. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. AN Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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III.	Indications for Use
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

page 1 of 1

MONARCH Spine System Spinal Rod Device Name:

Indications For Use:

The MONARCH Spine System is also indicated for pedicle screw fixation for Grade 3 and 4 spondylolisthesis at L5-S1, in skeletally mature patients, utilizing Shado o and '1 spenay.com the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K021148

Regulation Number and Section

N/A