K Number

Device Name

Manufacturer

SYNTHES (USA)

Date Cleared

2002-04-15

(55 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS and the Dual-Opening USS are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small statue) as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, the Synthes Small Stature USS and the Dual-Opening USS are intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including small stature) and pediatric patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.

When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Small Stature USS and the Dual-Opening USS are intended for scoliosis, Schuermann's disease, degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.

The anterior components of the Synthes Small Stature USS and the Dual-Opening USS when used in skeletally mature patients (including small stature) and pediatric patients are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-L5).

In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix™ System. When used with 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Universal Spinal System and the Dual-Opening USS.

Device Description

Synthes Dual-Opening USS consists of rods, plate/rods, clamps, screws, nuts and transconnectors. The implants are composed of Titanium or Stainless Steel.

AI/ML Overview

The provided text is a 510(k) summary for the Synthes Dual-Opening USS. It outlines the device's components, indications for use, and the FDA's clearance of the device based on substantial equivalence to a predicate device.

However, the document does not contain any information regarding acceptance criteria or a study that rigorously proves the device meets specific performance metrics.

Therefore, I cannot fulfill your request for the following information:

A table of acceptance criteria and the reported device performance: This information is not present in the document.
Sample size used for the test set and the data provenance: This information is not present. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set or ground truth establishment in this context.
Adjudication method for the test set: Not applicable.
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 device is a surgical implant, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

Device Description: Synthes Dual-Opening USS consists of rods, plate/rods, clamps, screws, nuts, and transconnectors made of Titanium or Stainless Steel.
Indications for Use:
- Posterior pedicle screw fixation system: For immobilization and stabilization of spinal segments in skeletally mature patients (including small stature) as an adjunct to fusion for acute and chronic instabilities or deformities (degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion).
- Specific for severe spondylolisthesis (Grade 3 and 4) of L5-S1: In skeletally mature and pediatric patients receiving fusion by autogenous bone graft, with implants attached to L3-S2 and removal after solid fusion.
- Posterior non-pedicle screw fixation system: In skeletally mature and pediatric patients for scoliosis, Scheuermann's disease, degenerative disc disease (back pain of discogenic origin with degeneration confirmed by history and radiographs), and fractures of the posterior thoracolumbar spine.
- Anterior components: In skeletally mature and pediatric patients for anterolateral screw and/or staple fixation for correction of anterolateral lordotic deformities, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (T8-L5).
- Connectivity: Can be linked to CerviFix™ System (with 3.5/5.0 mm parallel connectors) and Universal Spinal System and Dual-Opening USS (with 5.0/6.0 mm parallel connectors).
Regulatory Clearance: The FDA found the device substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The regulatory number is K020517.

Summary

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Synthes Spine 510(k) Premarket Notification Synthes Dual-Opening USS Special 510K

K02051/
page 1 of 2

8.4 ATTACHMENT IV - 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

DEVICE

Synthes Dual-Opening USS consists of rods, plate/rods, clamps, screws, nuts and transconnectors. The implants are composed of Titanium or Stainless Steel.

INDICATIONS

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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 image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image. The logo is black and white.

Public Health Service

APR 1 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vikki Hoffman Senior Regulatory Affairs Specialist Synthes Spine Post Office Box 0548 1690 Russell Road Paoli, Pennsylvania 19301

Re: K020517

Trade Name: Synthes Dual Opening USS 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: MNI, MNH, KWP Dated: March 22, 2002 Received: March 25, 2002

Dear Ms. Hoffman:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have and we have determined the device is substantially equivalent (for the indications for use above and we nave acteriners marketed in interstate commerce prior to May 28, 1976, the stated in the of the Medical Device Amendments, or to devices that have been reclassified in enconnent unte of the Firstians of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provincies of arts the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, controls provisions or use, 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 ( Femanel 1 pp . 0 w/s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 inspotworld 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 - Ms. Vikki Hoffman

This letter will allow you to begin marketing your device as described in your 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 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" (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,
for Mark N. Milliken
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

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8.2 ATTACHMENT II – INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KOQ OJ 7

Device Name: Synthes Dual-Opening USS

Indications for Use:

When used as a posterior pedicle screw fixation system, the Synthes Small Stature USS willing about as a points USS are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients (including small statue) as an adjunct to Spinal segments in sites of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, the Synthes Small Stature USS and the Dual-Opening USS are intended for in additions are of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients (including small stature) and pediatric patients receiving fusion by mature part having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.

When used as a posterior non-pedicle screw fixation system in skeletally mature patients (including small stature) and pediatric patients, the Synthes Small Stature USS and the Duel Opening USS are intended for scoliosis, Schuermann's disease, degenerative disc Disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), and fractures of the posterior thoracolumbar spine.

Mark N. Milbersen

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

510(k) Number -

CONFIDENTIAL

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

for Mark N Mulkerson
Division Sign Off

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020517

CONFIDENTIAL

Regulation Number and Section

N/A