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) decenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) lyphosis, (6) spinal tumor, 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: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) 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 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 pattent history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scollosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) fulled previous fusion.

When used as an anterolateral thoracio/lumbar system, the DYNALOK CLASSIC™ Spinel System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogonic origin with degeneration of the dise 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 @ Spiral System, CD HORIZON ® Spinal System, and TENOR™ Spinal System.

DYNALOK CLASSIC"M Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium alloy described by such standards as ASTM F136 of ISO 5832-3. Never use stainless steel and titanium implant components in the same construct.

AI/ML Overview

The provided text describes the DYNA-LOK CLASSIC™ Spinal System and its 510(k) summary for FDA clearance. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

Description of the device: Components and materials.
Indications for Use: Detailed descriptions of patient conditions for which the device is intended.
Regulatory Clearance: FDA's substantial equivalence determination to predicate devices.
Risk Analysis: A statement that a risk analysis was performed.

There is no mention of the following:

Acceptance criteria table or reported device performance.
Sample size for test sets or data provenance. (There are no test sets described.)
Number or qualifications of experts for ground truth. (No ground truth establishment is described.)
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm-only) performance. (This is a physical device, not an algorithm.)
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document is a regulatory submission for a physical medical device, not a software or AI-based device, and therefore the concepts of "test set," "training set," "ground truth," "MRMC studies," or "algorithm performance" do not apply in the context of this specific 510(k) summary. The "Functionality & Safety Testing" section only states that a Risk Analysis was performed; it does not detail any specific performance testing or acceptance criteria.

Summary

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

020155

DYNA-LOK CLASSIC™ Spinal System 510(k) Summary

FEB 0 5 2002

January 2002

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

II. Proposed Proprietary Trade Name: DYNA-LOK CLASSIC™ Spinal System

III. Description

Meditonic Sofamor Danek expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, express, or implied, are made. Implied warranties of morchantability and fitness for a particular purpose or use are specifically excluded.

To achieve best results and unless stated otherwise in another Medronic 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

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

DYNA-LOK CLASSIC™ Spinal System 510(k) Summary

substituted in their place. Hooks may only be used posteriorly and provided that the metal alloys are compatible,)

Indications for Use IV.

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DYNA-LOK CLASSICTM Spinal System is indicated for one 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 (psoudatthrosis).

In addition, when used as a pedicle screw fixation system, the DYNA-LOK CLASSIC™ Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (1.3 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 DYNA-LOK CLASSIC™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with dogeneration 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. When used as an antercolateral thoracic/lumbar system, the DYNA-LOK 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.

V. Functionality & Safety Testing:

A Risk Analysis was performed on the DYNA-LOK CLASSIC™ Spinal System and is included in this submission.

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

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 symbol that resembles a stylized caduceus, which is a symbol often associated with healthcare and medicine.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K020155

Trade/Device Name: DYNA-LOK® CLASSIC Spinal System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, Pedicle Screw Spinal System Regulatory Class: Class II Product Code: KWP, KWQ, MNH and MNI Dated: January 15, 2002 Received: January 17, 2002

FEB 0 5 2002

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. Richard 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

R. Mark N. Milliman

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}------------------------------------------------

510(k) Number (if known):

DYNA-LOK CLASSICTM Spinal System Device Name:

Indications for Use:

When used as a pedicio 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) decenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) lyphosis, (6) spinal tumor, 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: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) 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 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 pattent history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scollosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) fulled previous fusion.

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

Concurrence of CDRH, Office of Evaluation (ODE)

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

Over-the-counter Use
Mark N Millkern

Division Sign-Off Division of General, Restorative and I surological Devices

510(k) Number K020155

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.