(20 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
This device is a spinal system intended for various medical conditions of the spine, which falls under the definition of a therapeutic device.
No
The device description indicates it is a "posterior plate system" comprised of "anatomical shaped plates and bone screws," used for spinal fixation in surgical procedures. It is a treatment device, not a device used to identify, evaluate, or monitor medical conditions.
No
The device description clearly states it is comprised of anatomical shaped plates, bone screws, and blockers, all fabricated from Titanium alloy. These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this is a spinal system comprised of plates, screws, and blockers intended for surgical implantation to stabilize the spine for various conditions like scoliosis, fractures, and degenerative disc disease. It is a physical implant used in the body, not a device used to test samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Osteonics® Spinal System Rod/Plate System and Techtonix™ System are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
87 MNH, 87 KWP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T4-S2 spine, non-cervical posterior spine, L5-S1 joint, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing demonstrated comparable mechanical properties to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
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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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.
3
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
4
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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