When used as an anterior, thoracic/lumbar screw fixation system, the Centaur™ Spinal System is intended to treat deformities of curvature (i.e. scoliosis, kyphosis and/or lordosis), fracture, tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e.discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Description

The Centaur "Spinal System is a spinal fixation device for the noncervical spine. All components are manufactured from ISO 5832/3 (ASTM F-136-96) titanium alloy (Ti6Al-4V ELI). The system consists of primary and secondary screws, rods, lateral connectors, plates, and accessories.

Bone Screws: There are two different types of screws in the Centaur" Spinal System. They are primary and secondary screws. The head of the primary screw receives the connectors and the tightening screws for both the plate and rod systems. The head of the secondary screw is shaped to allow for a 5° angulation in all directions. Both the primary and secondary screws are threaded at the distal end. The distal aspect of the screws feature cancellous bone threads. Screws are available in two diameters: 5.5mm and 7mm, and in lengths of 25mm (in 5mm increments).

Rods: There are two types of spinal rods used in the Centaur" Spinal System. The first type is 4mm in diameter and the second type is 6mm in diameter. Both types range in length from 60mm to 160mm in 10mm increments. Rods are slipped into the rod connector and ball ring and are tightened down by rod locking screws. The rod connectors have a specific anatomic shape. They can be adapted to both the antero-posterior and craniocaudal shape of the lateral vertebra. A ball ring allows for a +1-15 angulation of the 6mmod. The posterior aspect of the rod system uses the larger rods, and this is the aspect that has the higher profile when implanted. The anterior aspect of the rod system uses the smaller rods which have the lower profile of the implant.

Plates: There are three types of plates used in the Centaur" Spinal System. All three are L-shaped. The first type, straight plates, range from 30mm in length in 10mm increments The second type, lordotic plates, range from 60mm to 90mm in length in 10mm increments. The third type, kyphotic plates, range in length from 50mm in 10mm increments. The plate system is not monoblock, thereby allowing more flexibility and greater opportunity for compression which aids fusion. Plates are assembled to the screws through the use of a plate connector and are locked down by set screws.

AI/ML Overview

Here's an analysis of the provided text regarding the Centaur™ Spinal System's acceptance criteria and studies, organized according to your requested information.

It's important to note that the provided 510(k) summary (K994347) is for a spinal fixation system, not a device that involves AI, diagnostic imaging, or human reader performance. Therefore, many of your requested items, which are typical for AI/diagnostic device submissions, are not applicable to this medical hardware submission. The information provided heavily emphasizes mechanical and material equivalence.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from predicate device equivalence)	Reported Device Performance (Centaur™ Spinal System)
Substantial equivalence to predicate device (MOSS Miami Spinal System) in intended use and basic design concepts.	Demonstrated comparable mechanical and endurance properties to the MOSS Miami Spinal System.
Components manufactured from ISO 5832/3 (ASTM F-136-96) titanium alloy (Ti6Al-4V ELI).	Components are manufactured from ISO 5832/3 (ASTM F-136-96) titanium alloy (Ti6Al-4V ELI).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this type of device submission. The "test set" in this context refers to mechanical testing of the physical device components, not a dataset of patient images or clinical outcomes. The submission focuses on device equivalence through material specifications and mechanical performance data, not clinical data provenance.

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

This information is not applicable. "Ground truth" in this context would refer to expert consensus on clinical findings or pathology, which is not relevant for a mechanical spinal implant. The "ground truth" for mechanical testing is typically engineering specifications and established test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are used for disagreements in human reader assessments, which are not part of this device's evaluation.

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

This information is not applicable. This is a spinal hardware system, not an AI or diagnostic imaging device that involves human readers interpreting cases.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on mechanical engineering standards and established material properties. The device's performance is compared against the known performance characteristics of the predicate device and the specified material (Ti6Al-4V ELI).

8. The sample size for the training set

This information is not applicable. The concept of a "training set" applies to machine learning models, not to the development and testing of a physical spinal implant.

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

This information is not applicable, as there is no "training set" in the context of this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the Centaur™ Spinal System meets the acceptance criteria is described as a comparison to a predicate device and mechanical testing.

The acceptance criterion is primarily demonstrating substantial equivalence to the predicate device, the MOSS Miami Spinal System (K983583), in terms of intended use, basic design concepts, and material.

The study presented to establish this equivalence involved:

Statement of Technological Comparison: The submission explicitly states that the Centaur™ Spinal System shares the same intended use and basic design concepts as the MOSS Miami Spinal System.
Material Equivalence: Both systems use ISO 5832/3 (ASTM F-136-96) titanium alloy (Ti6Al-4V ELI), which has a "long and successful history of use in orthopedic implant surgery."
Mechanical Testing: The crucial evidence provided is that "Fatigue and static testing demonstrates the comparable mechanical and endurance properties of these components" when compared to the predicate device. While specific numbers for fatigue and static loads are not detailed in the summary, the statement indicates that such tests were performed and showed comparable results.

In essence, the "study" for the Centaur™ Spinal System was a bench-top engineering evaluation demonstrating material compatibility and equivalent mechanical performance to a previously cleared device. It's a technical dossier proving physical and functional equivalence, rather than a clinical study evaluating diagnostic accuracy or treatment outcomes.

Summary

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

K994347

510(k) - Premarket Notification Summary of Safety and Effectiveness for the Centaur™ Spinal System

Submission Information

Dev

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.
	59 Route 17
	Allendale, NJ 07401-1677
Contact Person:	Mary-Catherine Dillon
	Regulatory Affairs Team Member
Date of Summary Preparation:	December 21, 1999

vice Identification
Proprietary Name:	CentaurTM Spinal System
Common Name:	Spinal Fixation Appliance

Classification Name and Reference:	Spinal Interlaminal Fixation Orthosis21 CFR §888.3050

Predicate Device Identification

The features of the Centaur" Spinal System are substantially equivalent to the features of the following DePuy AcroMed predicate device, which has been cleared for marketing via the 510(k) process (K983583):

· MOSS Miami Spinal System

Device Description

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

the distal end. The distal aspect of the screws feature cancellous bone threads. Screws are available in two diameters: 5.5mm and 7mm, and in lengths of 25mm (in 5mm increments).

Intended Use:

When used as an anterior, thoracic/lumbar screw fixation system, the Centaur" Spinal System is intended to treat deformities of curvature (i.e. scoliosis, kyphosis and/or lordosis), fracture. tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e.discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Statement of Technological Comparison:

The Centaur" Spinal System shares the same intended use and basic design concepts as those of the predicate DePuy AcroMed MOSS Miami Spinal System. Fatigue and static testing demonstrates the comparable mechanical and endurance properties of these components.

The components of the Centaur" Spinal System are manufactured from titanium alloy (Ti6Al-4V ELI). This material has a long and successful history of use in orthopedic implant surgery.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2000

Ms. Mary-Catherine Dillon Regulator Affairs Team Member Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K994347

Trade Name: CENTAUR Spinal System Regulatory Class: II Product Code: KWQ Dated: December 21, 1999 Received: December 23, 1999

Dear Ms. Dillon:

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 control provisions of the Act. The general control 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.

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.

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

Page 2 - Ms. Mary-Catherine Dillon

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 vours.

Neil R. Ogden

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

Enclosure

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

510(k) Number (if known): K 994347

Device Name: Centaur™ Spinal System

Indications For Use:

When used as an anterior, thoracic/Jumbar screw fixation system, the Centaur™ Spinal System . is intended to treat deformities of curvature (i.e. scoliosis, kyphosis and/or lordosis), fracture, tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e.discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use_ Prescription Use メ OR :

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Division Sign-Off)	NPO DC
Division of General Restorative Devices	CMW
510(k) Number	K994347

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.