(80 days)
The subject components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein. are available in either ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6Al4V Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6Al4V alloy components are intended for use only with other Ti6Al4V alloy components.
The specific indications of the Osteonics® Spinal System, including the subject additional components, are stated below:
For non-pedicular use:
- . Long and short curve scoliosis.
- Vertebral fracture or dislocation.
- . Spondylolisthesis,
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
For pedicular use:
- . When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.
The Osteonics® Spinal System Top Loading Transverse Connector Assembly allows a spinal construct on one side of the spine to be joined to another construct on the other side of the spine. This joining provides additional resistance to physiological forces such as unequal lateral loads, rotation, and isolated torsional movements. Construction of this assembly requires two Osteonics® Spinal System Top Loading Transverse Connectors, each with a Top Loading Connector Set Screw, and a Transverse Connector Bar. Each top loading transverse connector joins one end of the transverse connector bar to one of the longjtudinal construct. The top loading connector set screw is used to secure the transverse assembly.
The provided text describes a 510(k) premarket notification for a medical device, the Osteonics® Spinal System -Top Loading Transverse Connector Assembly. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in clinical trials for novel devices.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test and training sets, expert qualifications, ground truth methodologies, and MRMC studies, is not present in the provided document.
Instead, the document details:
- Predicate Device Identification: It explicitly states that the new components are "substantially equivalent to other legally marketed spinal system crosslinking (transversing) assembly components."
- Predicate Devices Listed: Osteonics® Spinal System, TSRH™ Spinal System, GDLH™ Posterior Spinal System, and ISOLA Spinal System.
- Technological Comparison: "The components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly share the same materials, intended uses and basic design concepts as that of the predicate devices."
- Mechanical Testing: It mentions that "Fatigue and static testing demonstrates the mechanical and endurance properties of these components." This is the primary "study" referenced, but no specific acceptance criteria or performance results from these tests are provided in the summary.
In summary, the provided text is a regulatory submission summary demonstrating substantial equivalence based on materials, intended use, basic design, and general mechanical testing, not a clinical study report with detailed performance metrics against specific acceptance criteria.
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JAN 17 1997
964304 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® SPINAL SYSTEM -TOP LOADING TRANSVERSE CONNECTOR ASSEMBLY
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900
Regulatory Affairs Specialist
TO
Contact Person:
Date Summarv Prepared:
Device Identification Proprietary Name:
January 9, 1997
Donna S. Wilson
Osteonics® Spinal System -Top Loading Transverse Connector Assembly
Common Name:
Classification Name and Reference:
Spinal Interlaminal Fixation Orthosis
Spinal Fixation Appliances
21 CFR 888 3050
Predicate Device Identification
The Osteonics® Spinal System Top Loading Transverse Connector Assembly components are substantially equivalent to other legally marketed spinal system crosslinking (transversing) assembly components. These predicate components are part of the commercially available spinal systems stated below:
- Osteonics® Spinal System: Osteonics Corp. .
- . TSRH™ Spinal System: Sofamor Danek
- GDLH™ Posterior Spinal System: Sofamor Danek
- ISOLA Spinal System: Acromed .
Device Description
The Osteonics® Spinal System Top Loading Transverse Connector Assembly allows a spinal construct on one side of the spine to be joined to another construct on the other side of the spine. This joining provides additional resistance to physiological forces such as unequal lateral loads, rotation, and isolated torsional movements. Construction of this assembly requires two Osteonics® Spinal System Top Loading Transverse Connectors, each with a Top Loading Connector Set Screw, and a Transverse Connector Bar. Each top loading transverse connector
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joins one end of the transverse connector bar to one of the longjtudinal construct. The top loading connector set screw is used to secure the transverse assembly.
TO
Intended Use
The subject components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly are single-use devices which are sold non-sterile, and are intended for use only with other components of the commercially available Osteonics® Spinal System. The components of the Osteonics® Spinal System, including the additional components described herein. are available in either ASTM F-138 Stainless Steel (Type 316 LVM) or ASTM F-136 Ti6Al4V Alloy. Stainless steel components are intended for use only with other stainless steel components; Ti6Al4V alloy components are intended for use only with other Ti6Al4V alloy components.
The specific indications of the Osteonics® Spinal System, including the subject additional components, are stated below:
For non-pedicular use:
- . Long and short curve scoliosis.
- � Vertebral fracture or dislocation.
- . Spondylolisthesis,
- . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
For pedicular use:
- . When used as a pedicle screw system, the system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 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; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.
Statement of Technological Comparison
The components of the Osteonics® Spinal System Top Loading Transverse Connector Assembly share the same materials, intended uses and basic design concepts as that of the predicate devices. Fatigue and static testing demonstrates the mechanical and endurance properties of these components.
N/A