When used as a pedicle screw fixation system of the non-cevical posterior spine in skeletally mature patients, the Opus" Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
In addition, the Opus" Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

Device Description

The Opus" Spinal System is a spinal fixation device for the noncervical spine. All components are manufactured from ISO 5832/3 (equivalent to ASTM F-136-96) titanium alloy (Ti6Al-4V ELL). The system consists of conical and cylindrical screws, rods, lateral connectors, and plates.
Bone Screws: These screws are threaded at both the distal and the proximal ends. The distal aspect of the screws features cancellous bone threads. The proximal aspect of the screws features standard metric threads. The area between the proximal and distal threads has a hexagonal cross-section used to remove the screw. Screws are available in a variety of diameters and lengths. Additionally, the screws are available in extended proximal length and/or extended hexagonal section configurations.
Rods: The spinal rods are 6mm in diameter and range in length from 40mm to 480mm. A 600mm rod is also available. Rods are assembled to the screws through the use of a lateral connector and a rod nut.
Plates: The plates have 2 or 3 holes and their lengths range from 41mm to 75mm. Plates are assembled to the screws through the use of a washer and a plate nut.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Opus™ Spinal System, a medical device for spinal fixation. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific performance criteria.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense (e.g., sensitivity, specificity, AUC for an AI/diagnostic device) does not apply here. Instead, the "acceptance criteria" are related to mechanical and material equivalence to the predicate device, and the "study" is a comparison of these properties.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a spinal fixation system, the "acceptance criteria" are implicitly tied to demonstrating mechanical and material equivalence and safety/effectiveness comparable to a predicate device. There are no explicit performance metrics like sensitivity or specificity.

Acceptance Criteria (Implicit)	Reported Device Performance (as stated in the document)
Material Equivalence	All components are manufactured from ISO 5832/3 (equivalent to ASTM F-136-96) titanium alloy (Ti6Al-4V ELL). The Opus™ Spinal System shares the `same material (titanium alloy (Ti6Al-4V ELI))` as the predicate.
Functional/Design Concept Equivalence	The Opus™ Spinal System shares `basic design concepts` with the predicate Osteonics® Spinal System.
Mechanical/Endurance Property Equivalence	`Fatigue and static testing demonstrates the comparable mechanical and endurance properties` of these components.
Intended Use Equivalence	The Opus™ Spinal System shares the `same intended uses` as the predicate Osteonics® Spinal System, which are detailed in the "Indications For Use" section. These include specific conditions and patient demographics for pedicle screw fixation in the non-cervical posterior spine.

Study Information

Sample size used for the test set and the data provenance:
- No human subject test set or data provenance is mentioned as this device relies on mechanical testing and material comparison to a predicate, not clinical performance data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a clinical test set is not relevant for this 510(k) submission type.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no clinical test set requiring adjudication.
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 is not an AI/diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a spinal implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical aspects, the "ground truth" would be the established mechanical and material specifications of the predicate device and industry standards (e.g., ISO 5832/3, ASTM F-136-96). The "study" involves demonstrating that the Opus™ Spinal System's mechanical and material properties meet or exceed these established benchmarks, or are comparable to the predicate.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K993402

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

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677
Contact Person:	Mary-Catherine DillonRegulatory Affairs Specialist
Date of Summary Preparation:	September 30, 1999
Device Identification
Proprietary Name:	Opus™ 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 Opus" Spinal System are substantially equivalent to features of the following Howmedica Osteonics predicate device, which has been cleared for marketing via the 510(k) process (K951725):

· Osteonics® Spinal System

Device Description

Bone Screws: These screws are threaded at both the distal and the proximal ends. The distal aspect of the screws features cancellous bone threads. The proximal aspect of the screws features standard metric threads. The area between the proximal and distal threads has a hexagonal cross-section used to remove the screw. Screws are available in a variety of diameters and lengths. Additionally, the screws are available in extended proximal length and/or extended hexagonal section configurations.

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Rods: The spinal rods are 6mm in diameter and range in length from 40mm to 480mm. A 600mm rod is also available. Rods are assembled to the screws through the use of a lateral connector and a rod nut.

Plates: The plates have 2 or 3 holes and their lengths range from 41mm to 75mm. Plates are assembled to the screws through the use of a washer and a plate nut.

Intended Use:

· When used as a pedicle screw fixation system of the non-cevical posterior spine in skeletally mature patients, the Opus" Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
· In addition, the Opus" Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

Statement of Technological Comparison:

The components of the Opus" Spinal System share the same material (titanium alloy (Ti6Al-4V ELI)), intended uses, and basic design concepts as those of the predicate Osteonics® Spinal System. Fatigue and static testing demonstrates the comparable mechanical and endurance properties of these components.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 20 1999

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

Re: K993402 Trade Name: Opus™ Spinal System Regulatory Class: II Product Codes: MNI and MNH Dated: October 6, 1999 Received: October 8, 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 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). 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 requirements, 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 - Ms. Mary-Catherine Dillon

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) 594-4595. 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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Neil RP Ogden
James E. Dillard III

James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 99 3402

Device Name: Opus™ Spinal System

Indications For Use:

· When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Opus" Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
· In addition, the Opus™ Spinal System is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions using autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

Sign-Off

Division Sign-Off) Division of General Restorative Devic 993402 510(k) Number

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

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

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.