K Number

Validate with FDA (Live)

Device Name

DYNALOK CLASSIC SPINAL SYSTEM

Manufacturer

MEDTRONIC SOFAMOR DANEK

Date Cleared

2003-11-06

(27 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNALOK CLASSIC™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNALOK CLASSIC™ Spinal System is indicated for skeletally mature patients: {1} having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (13 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the DYNALOK CLASSIC™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kychosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. When used as an anterolateral thoracic/lumbar system, the DYNALOK CLASSIC™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

Device Description

The DYNALOK CLASSIC™ Spinal System consists of a variety of shapes and sizes of plates, bolts, screws, washers, nuts, spacers, CROSSLINK® Plates, and connecting components. The DYNALOK CLASSIC™ Spinal System components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Additionally, the DYNALOK CLASSIC™ Spinal System may be used in conjunction with TSRH ® Spinal System, CD HORIZON ® Spinal System, and TENOR™ Spinal System.

DYNALOK CLASSIC™ Spinal System implant components are fabricated from medical grade stainless steel. Alternatively, the entire system may be made out of medical grade titanium alloy. Never use stainless steel and titanium implant components in the same construct.

To achieve best results and unless stated otherwise in another Medtronic Sofamor Danek document, do not use any of the DYNALOK CLASSIC™ Spinal System components with the components from any other system. (NOTE: In addition to the DYNALOK CLASSIC™ rod bolt connectors and bolts, a surgeon may want to connect a spinal rod to CD HORIZON® hooks. The hooks would be applied as stated in the CD HORIZON® Spinal System package insert. However, instead of using the fixed angle CD HORIZON® bone screws or multi axial screws, the DYNALOK CLASSIC™ rod bolt connector and bolt would be substituted in their place. Hooks may only be used posteriorly and provided that the metal alloys are compatible.)

The purpose of this submission is to include an alternative minimally invasive surgical technique to the system.

AI/ML Overview

The provided text is a 510(k) summary for the DYNALOK CLASSIC™ Spinal System. It details the device's description, indications for use, and a declaration of substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, this is a regulatory filing focused on demonstrating equivalence to an already approved device for an additional surgical technique. It does not include:

Acceptance Criteria or Device Performance Table: No such table is present.
Sample Size or Data Provenance for Test Set: No specific test set data is mentioned. The submission is based on the premise that no new or modified components are added, and thus no new risks are posed by the alternative surgical technique.
Number of Experts/Qualifications for Ground Truth: No expert review or ground truth establishment is described.
Adjudication Method: Not applicable as no ground truth establishment is detailed.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned or implied, as this is a device modification submission, not an AI or diagnostic tool.
Standalone Performance Study: No algorithm-only study is applicable or described.
Type of Ground Truth Used: Not applicable, as the submission focuses on device equivalence, not diagnostic accuracy.
Sample Size for Training Set & Ground Truth for Training Set: These are not relevant to this type of device submission and are not mentioned.

The core of this 510(k) summary is the statement: "No new components were added to the system, as the sole change is the addition of an alternative surgical technique that is left to the discretion of the surgeon. The proposed technique requires no new or modified components, nor does it pose any additional risks. Therefore, the subject submission is substantially equivalent to the predicate DYNALOK CLASSIC™ Spinal System." This indicates that the device's safety and effectiveness are deemed equivalent to an already approved device based on the lack of material change, rather than new testing against defined acceptance criteria.

Summary

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

DYNALOK CLASSIC™ Spinal System 510(k) Summary

October 2003

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

Proposed Proprietary Trade Name: DYNALOK CLASSIC™ Spinal System II.

III. Regulation Name: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Fixation Orthosis, Pedicle Screw Spinal System
IV. Regulation Number: 888.3050, 888.3060, 888.3070
V. Description

The purpose of this submission is to include an alternative minimally invasive surgical technique to the system.

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

DYNALOK CLASSIC™ Spinal System 510(k) Summary

VI. Indications for Use

VII. Substantial Equivalence:

No new components were added to the system, as the sole change is the addition of an alternative surgical technique that is left to the discretion of the surgeon. The proposed technique requires no new or modified components, nor does it pose any additional risks. Therefore, the subject submission is substantially equivalent to the predicate DYNALOK CLASSICTM Spinal System.

C2003 Medtronic Sofamor Danek

{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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 2003

Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K033271

Trade Name: DYNALOK™ CLASSIC Spinal System - Modification of Surgical Procedure Regulation Number: 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Intervertebral Body Fixation Orthosis, Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: MNI, MNH, KWQ, KWP Dated: October 8, 2003 Received: October 10, 2003

Dear Dr. Treharne:

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, 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); 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.

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

Page 2 - Dr. Rick Treharne

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark A. Mulkerin

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

Enclosure

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

KO332 510(k) Number (if known):___

DYNALOK CLASSICTM Spinal System Device Name:

Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNALOK CLASSIC™ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) dislocation, (4) scoliosis, (5) kyphosis. (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DYNALOK CLASSIC™ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbarfirst sacral (L5-S1) vertebral joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as an anterolateral thoracic/lumbar system, the DYNALOK CLASSIC™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

Over-the-counter Use

for Mark N. Millison

al, Restorative Neurological /

510(k) Number

00044

Regulation Number and Section

N/A