(30 days)
The Multi-Axis Cross-Connectors are intended to be used with the other components of the 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.
The Opus" Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the system. The components of the system are manufactured from ISO 5832/3 Titanium Alloy (Ti-6Al-4V). The plates for the Opus™ Spinal System range from 41-75 mm in length. Longer plates will be added to the Opus" Spinal System in order to cover the maximum of surgical configurations. The three additional subject plates will range in length from 90 -120 mm.
The provided text describes a 510(k) submission for a modification to the Opus™ Spinal System, specifically adding longer plates. The submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. There is no information in the provided text about a study involving human readers, AI, or ground truth derived from expert consensus, pathology, or outcomes data, as the device is a spinal fixation system, not a diagnostic or AI-driven tool.
Therefore, many of the requested categories are not applicable to this type of device and study.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical properties comparable to predicate constructs (Fatigue testing) | Fatigue testing demonstrates comparable mechanical properties of the subject Opus™ Spinal System and MAC construct to the predicate constructs. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size (number of test specimens) used for the fatigue testing. The data provenance is implied to be from internal testing by Howmedica Osteonics Corp, located in Allendale, NJ, USA. The testing is for a device modification, implying a prospective evaluation of newly manufactured components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for mechanical performance is established through standardized engineering tests, not expert human interpretation.
4. Adjudication method for the test set
Not applicable. Mechanical testing does not involve adjudication.
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
Not applicable. This is a medical device (spinal implant), not a diagnostic imaging or AI-assisted system. No human reader or AI interaction is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used
The ground truth for this device is based on mechanical testing standards and direct physical measurement of properties like fatigue resistance, ensuring the modified device maintains structural integrity and performance equivalent to the predicate device.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Summary of Safety and Effectiveness Line Extension Opus Spinal System
JAN 2 5 2002
Submission Information
Device
| Name and Address of the Sponsorof the 510(k) Submission | Howmedica Osteonics Corp59 Route 17Allendale, NJ 07401-1677 |
|---|---|
| Contact Person: | Karen AriemmaRegulatory Affairs Specialist |
| Date of Summary Preparation: | December 21, 2001 |
| ce Identification | |
| Proprietary Name: | Opus™ Spinal System |
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Spinal Interlaminal Fixation Orthosis21 CFR 888.3050 |
| Pedicle Screw Spinal System21 CFR 888.3070 |
Predicate Device Identification
The Opus™ Spinal System was determined substantially equivalent via 510(k) K993402. The Multi-Axial Cross-Connector (MAC) was determined substantially equivalent for use with the Opus " Spinal System via 510(k) K013688. The Opus" Spinal System is made up of a range of screws, which are compatible with both the rod and plate components of the system. The components of the system are manufactured from ISO 5832/3 Titanium Alloy (Ti-6Al-4V). The plates for the Opus™ Spinal System range from 41-75 mm in length.
Description of Device Modification
Longer plates will be added to the Opus" Spinal System in order to cover the maximum of surgical configurations. The three additional subject plates will range in length from 90 -120 mm.
Intended Use:
The MAC is intended to be used with the other components of the Opus™ Spinal System.
Indications For Use:
The Opus" Spinal System is intended for fixation of the T4-S2 spine. The specific indications for the Opus" Spinal System are as follows:
{1}------------------------------------------------
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 neurologic 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:
Fatigue testing demonstrates the comparable mechanical properties of the subject Opus™ Spinal System and MAC construct to the predicate constructs.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 5 2002
Ms. Elizabeth A. Staub Vice President Quality Assurance/Regulatory Affairs/ Clinical Research Howmedica Osteonics Incorporated 59 Route 17 Allendale, New Jersey 07401-1677
K014229 Re: Trade Name: OPUSTM Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Spondylolisthesis Spinal Fixation System, Pedicle Screw Fixation System Regulatory Class: II Product Code: MNH, MNI Dated: December 21, 2001 Received: December 26, 2001
Dear Ms. Staub:
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 tof 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 provisions of the reactal controls provisions of the Act. The general controls provisions of the a . I holy sever to 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.
{3}------------------------------------------------
Page 2 -- Ms. Elizabeth A. Staub
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,
Sincerely yours,
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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510(k) Number (if known): K $ 1 4- 2 2 9
Device Name: Opus™ Spinal System
The Multi-Axis Cross-Connectors are intended to be used with the other components of the 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.
fo Mark N. Melkerss
ral. Restorative and Neurological Devices
510(k) Number K014229
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use > OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
N/A