(20 days)
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are indicated for:
- Long and short curve scoliosis
- Vertebral fracture or dislocation
- Spondylolisthesis
- Degenerative disc disease (defined as back pain of discogneic origin with degeneration of the disc confirmed by history and radiographic studies)
- Previously failed fusion
- Spinal tumor
Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are 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 (pseudoarthrosis).
- In addition, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with 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.
This submission is intended to expand the Osteonics® Spinal System Rod/Plate System product line by adding the Techtonix™ System, a low profile posterior plate system. Similar to its predicate device, the Techtonix™ System is comprised of anatomical shaped plates and bone screws available in a variety of lengths, and blockers (which tighten the bone screws to the plates). The components of the subject device are fabricated from Titanium alloy as described in ASTM F-136 and ISO 5832-3. The Techtonix™ System will be provided non-sterile.
This document is a 510(k) premarket notification for a line extension to an existing spinal system. It does not describe any acceptance criteria or studies related to computational device performance, algorithm evaluation, or AI assistance.
The document is for a physical medical device (spinal fixation system components) and primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Description of Device Modification: Adding low-profile posterior plate systems (Techtonix™ System) to the existing Osteonics® Spinal System Rod/Plate System.
- Materials: Both the predicate and subject devices are fabricated from Titanium alloy (ASTM F-136 and ISO 5832-3).
- Intended Use/Indications: The uses are expanded to explicitly include the Techtonix™ System, maintaining similar indications for non-pedicle and pedicle screw applications.
- Technological Comparison: Stating that components share intended use and basic design concepts, and that "Mechanical testing demonstrated comparable mechanical properties to the predicate devices."
Therefore, based on the provided text, I cannot answer most of your questions as they pertain to the evaluation of a computational device or AI system, which is not the subject of this 510(k) submission.
Here's what I can extract regarding the physical device's evaluation, though it doesn't align with the AI/computational evaluation framework:
-
Table of Acceptance Criteria and Reported Device Performance: Not provided in the document in the context of performance metrics that would be applicable to an AI or computational device. The document generally states "Mechanical testing demonstrated comparable mechanical properties to the predicate devices," implying that the acceptance criterion was likely that the new components perform at least as well as the predicate device in relevant mechanical tests. Specific numerical acceptance criteria or performance values are not disclosed.
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Sample Size Used for the Test Set and Data Provenance: Not applicable. This refers to mechanical testing of physical implants, not data analysis.
-
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. Ground truth in this context would likely be engineering specifications and results from mechanical testing, not expert consensus on medical images or patient data.
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Adjudication Method: Not applicable.
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Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable.
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Standalone Performance: Not applicable as it's a physical device. Its "performance" is measured through mechanical testing, not an algorithm's output.
-
Type of Ground Truth Used: For the mechanical testing, the "ground truth" would be established engineering standards, material properties, and comparison to the predicate device's established performance under those tests.
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Sample Size for the Training Set: Not applicable (no training set for a physical device).
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How the Ground Truth for the Training Set was Established: Not applicable.
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5050189
Line Extension to the Osteonics® Spinal System RPS
FEB 1 6 2005
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Osteonics® Spinal System Rod/Plate System (RPS)
| Proprietary Name: | Techtonix™ System |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class II |
| Spinal Interlaminal Fixation Orthosis, 21 CFR 888.3050 | |
| Pedicle Screw Spinal System, 21 CFR 888.3070 | |
| Device Product Code: | 87 MNH: Spondylolisthesis Spinal Fixation System |
| 87 KWP: Appliance, Fixation, Spinal Interlaminal | |
| For Information contact: | Simona Voic |
| Regulatory Affairs Project Manager | |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Telephone: (201) 760-8145 | |
| Fax: (201) 760-8345 | |
| Email: Simona.Voic@stryker.com |
Date Summary Prepared:
January 26, 2005
Predicate Device Identification
The features of the Techtonix " System are substantially equivalent to the features of the Osteonics Spinal System Rod/ Plate System (RPS) which was determined substantially equivalent via 510(k) K991055.
Description of Device Modification
This submission is intended to expand the Osteonics® Spinal System Rod/ Plate System product line by adding the Techtonix™ System, a low profile posterior plate system. Similar to its predicate device, the Techtonix™ System is comprised of anatomical shaped plates and bone screws available in a variety of lengths, and blockers (which tighten the bone screws to the plates). The components of the subject device are fabricated from Titanium alloy as described in ASTM F-136 and ISO 5832-3. The Techtonix™ System will be provided non-sterile.
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2
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Intended Use:
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are indicated for:
- Long and short curve scoliosis ●
- Vertebral fracture or dislocation .
- Spondylolisthesis �
- Begenerative disc disease (defined as back pain of discogneic origin with degeneration of . the disc confirmed by history and radiographic studies)
- Previously failed fusion .
- Spinal tumor ●
Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in . skeletally mature patients, the Osteonics Spinal System Rod/Plate System and Techtonix "M System are 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 (pseudoarthrosis).
- In addition, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are . indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with 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:
Statement of I cennonents share intended use and basic design concepts as that of the I ne sacreed von. Mechanical testing demonstrated comparable mechanical properties to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2005
Ms. Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K050189
Trade/Device Name: Osteonics® Spinal System Rod/Plate System and Techtonix™ System Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: MNH, KWP Dated: January 26, 2005 Received: January 27, 2005
Dear Ms. Voic:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Simona Voic
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millburn
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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Indications for Use
510(k) Number (if known): K
Device Name: Osteonics® Spinal System Rod/Plate System and Techtonix™ System
Indications For Use:
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics Spinal As a posterior, non-podiolo corrent and Techtonix™ System are indicated for:
- Long and short curve scoliosis .
- Vertebral fracture or dislocation .
- Spondylolisthesis .
- Degenerative disc disease (defined as back pain of discogneic origin with . Degeneration of the disc confirmed by history and radiographic studies)
- Previously failed fusion .
- . Spinal tumor
Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine . in skeletally mature patients, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are 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 (pseudoarthrosis).
- previous fusion (postubantikes).
In addition, the Osteonics® Spinal System Rod/Plate System and Techtonix™ . in duallen, indicated for pedicle screw fixation in skeletally mature patients with System and manaked is (Grades 3 and 4) at the L5-S1 joint, having fusions with 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.
AND/OR x Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRED office of Device Evaluation (ODE)
M
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number
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N/A