(69 days)
Not Found
No
The summary describes a mechanical spinal plating system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide "additional support during fusion" for various spinal conditions, indicating it is used to treat or manage a disease or condition in skeletally mature patients.
No
The device, the Stryker Spine THOR™ Anterior Plating System, is described as a system intended to provide additional support during spinal fusion, consisting of plates and screws. Its purpose is to stabilize the spine, not to identify or diagnose medical conditions.
No
The device description explicitly states that the system consists of plates and bone screws manufactured from Titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the spine during fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details plates and screws made of titanium alloy, designed for physical implantation. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to be used in vitro (outside the body) to diagnose diseases or conditions.
This device is a surgical implant used in vivo (inside the body) to provide structural support.
N/A
Intended Use / Indications for Use
The Stryker Spine THOR™ Anterior Plating System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels.
The Styker Spine THOR™ Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-S1). THOR™ Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- Degenerative disc disease (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
- Pseudoarthrosis; .
- Spondylolysis; .
- Spondylolisthesis; .
- Trauma (i.e., fracture or dislocation); .
- Deformities (i.e., scoliosis or lordosis)
- Spinal Stenosis; and
- Failed Previous Fusion. ●
Product codes
KWQ
Device Description
The Stryker Spine THORTM Anterior Plating System is designed for anterior and anterolateral stabilization of the lumbar and lumbosacral spine (L1-S1). The system consists of a variety of plates and bone screws manufactured from Titanium alloy. The plates have an anatomical shape design and are preassembled with rings to accommodate the insertion of bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and lumbosacral spine (L1-S1)
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)
Testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was performed for the THOR TM Anterior Plating System, and demonstrated equivalent mechanical performance characteristics to the Stryker Spine CENTAUR Spinal System [510(k) K994347, K001844] and Stryker Spine Xia Stainless Steel System [510(k) K012870]. THORTM system demonstrated equivalent material biocompatibility to the Stryker Spine CENTAUR Spinal System indicated above and is equivalent to the Synthes Anterior Tension Band System [510(k K022791] with respect to intended use.
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.
K022791, K994347, K001844, K012870
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Stryker Spine THOR™ Anterior Plating System
Traditional 510(k) Premarket Notification
510(k) Summary: THOR™ Anterior Plating System
| Submitter: | Stryker Spine
2 Pearl Court
Allendale, New Jersey 07401 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FEB 13 20 |
| Contact Person | Mr. Curtis Truesdale
Regulatory Affairs Project Manager
Phone: 201-760-8296
FAX: 201-760-8496
Email: curtis.truesdale@stryker.com |
| Date Prepared | February 8, 2008 |
| Trade Name | Stryker Spine THORTM Anterior Plating System |
| Proposed Class | Class II |
| Classification Name
and Number | Spinal Intervertebral Body Fixation Orthosis
21 CFR 888.3060 |
| Product Code | KWQ |
| Predicate Devices | Synthes Anterior Tension Band System: 510(k) #K022791
Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#K001844
Stryker Spine Xia Stainless Steel System: 510(k) #K012870 |
| Device Description | The Stryker Spine THORTM Anterior Plating System is designed
for anterior and anterolateral stabilization of the lumbar and
lumbosacral spine (L1-S1). The system consists of a variety of
plates and bone screws manufactured from Titanium alloy. The
plates have an anatomical shape design and are preassembled
with rings to accommodate the insertion of bone screws. |
| Summary of the | Testing in compliance with FDA's Guidance for Spinal System |
| Technological
Characteristics | 510(k)'s May 3, 2004 was performed for the THOR TM Anterior |
| | Plating System, and demonstrated equivalent mechanical
performance characteristics to the Stryker Spine CENTAUR
Spinal System [510(k) K994347, K001844] and Stryker Spine
Xia Stainless Steel System [510(k) K012870]. THORTM system
demonstrated equivalent material biocompatibility to the Stryker
Spine CENTAUR Spinal System indicated above and is
equivalent to the Synthes Anterior Tension Band System [510(k
K022791] with respect to intended use. |
1
The Stryker Spine THOR™ Anterior Plating System is indicated Intended Use for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels.
THOR™ Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-S1). THOR™ Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Trauma (i.e., fracture or dislocation); Deformities (i.e. scoliosis or lordosis); Spinal Stenosis; and Failed Previous Fusion.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
FEB 13 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K073437
Trade/Device Name: THORTM Anterior Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 5, 2007 Received: December 6, 2007
Dear Mr. Truesdale:
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 - Mr. Curtis Truesdale
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Stryker Spine THOR™ Anterior Plating System
Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K_
Device Name: Stryker Spine THOR™ Anterior Plating System
Indications For Use:
The Stryker Spine THOR™ Anterior Plating System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels.
The Styker Spine THOR™ Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-S1). THOR™ Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- Degenerative disc disease (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
- Pseudoarthrosis; .
- Spondylolysis; .
- Spondylolisthesis; .
- Trauma (i.e., fracture or dislocation); .
- Deformities (i.e., scoliosis or lordosis)
- Spinal Stenosis; and
- Failed Previous Fusion. ●
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (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 CDRH, Office of Device Evaluation (ODE)
barbare Buelud
(Division Sign-Off)
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510(k) Number K073437