(82 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of a spinal plating system, with no mention of AI or ML.
Yes
The device is intended to treat various acute and chronic instabilities or deformities of the spine through fusion, which is a therapeutic intervention.
No
Explanation: The device is an anterior plating system designed for stabilization during fusion procedures, not for diagnosing conditions.
No
The device description explicitly states that the system consists of physical components: "a variety of plates and bone screws manufactured from Titanium alloy." This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant system for stabilizing the spine during fusion procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a plating system made of titanium alloy, consisting of plates and screws. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
The device is clearly intended for direct surgical intervention and support of the spine, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as an anterior non-pedicle fixation system in the lumbar and lumbosacral spine (L1-S1), THOR Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels. 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 degenerative disc confirmed by history and radiographic studies);
-
- Pseudoarthrosis
-
- Spondylolysis
- Spondyloisthesis 4)
- Trauma (i.e. Fracture of Dislocation) 5)
- Deformities (i.e. Scoliosis or Lordosis) 6)
- Spinal Stenosis 7)
- Failed previous Fusion 8)
When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (T1-L5), THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skelefally 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 degenerative disc confirmed by history and radiographic studies)
-
- Trauma (i.e. Fracture or Dislocation)
-
- Spinal Stenosis
-
- Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis)
-
- Tumors
-
- Failed Previous Fusion
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Stryker Spine THOR™ Anterior Plating System is designed for anterior and anterolateral stabilization of the thoracic, lumbar and sacral spine. The system consists of a variety of plates and bone screws manufactured from Titanium alloy. The plates are preassembled with locking 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
thoracic, lumbar, sacral spine, lumbosacral spine (L1-S1), thoracic and thoracolumbar spine (T1-L5)
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 THORTM 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]. The subject THORTM system demonstrated equivalent material biocompatibility and intended use as the Stryker Spine CENTAUR Spinal System and the previously cleared THORTM Anterior Plating System [510(k) K073437].
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.
K073437, 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
h0773
Stryker Spine THOR™ Anterior Plating System
Traditional 510(k) Premarket Notification
JUN - 9 2008 510(k) Summary: THOR™ Anterior Plating System
Stryker Spine Submitter: 2 Pearl Court Allendale, New Jersey 07401
Mr. Curtis Truesdale Contact Person Regulatory Affairs Project Manager Phone: 201-760-8296 FAX: 201-760-8496 Email: curtis.truesdale(@stryker.com
March 17, 2008 Date Prepared
Stryker Spine THORTM Anterior Plating System Trade Name Class II Proposed Class Spinal Intervertebral Body Fixation Orthosis Classification Name 21 CFR 888.3060 and Number KWQ Product Code
- Stryker Spine THOR Anterior Plating System: 510(k) #K073437 Predicate Devices Stryker Spine CENTAUR Spinal System: 510(k) #K994347,#K001844 Stryker Spine Xia Stainless Steel System: 510(k) #K012870
- The Stryker Spine THOR™ Anterior Plating System is designed Device Description for anterior and anterolateral stabilization of the thoracic, lumbar and sacral spine. The system consists of a variety of plates and bone screws manufactured from Titanium alloy. The plates are preassembled with locking rings to accommodate the insertion of bone screws.
1
Indications for Use (continued)
When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (T1-L5), 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 degenerative disc confirmed by history and radiographic studies)
-
- Trauma (i.e. Fracture or Dislocation)
-
- Spinal Stenosis
-
- Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis)
-
- Tumors
-
- Failed Previous Fusion
2
Intended Use When used as an anterior non-pedicle fixation system, in the lumbar and lumbosacral spine (L1-S1), THOR™ Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach below the bifurcation of the great vessels. 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.
When used as an anterolateral non-pedicle fixation system, in the thoracic and thoracolumbar spine (TI-L5), 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 degenerative disc confirmed by history and radiographic studies);
3
- Trauma (i.e. fracture or dislocation); .
- Spinal stenosis; .
- Deformities (i.e. scoliosis, kyphosis and/or lordosis); .
- Tumors; and .
- Failed Previous Fusion. .
| Summary of the
Technological
Characteristics | Testing in compliance with FDA's Guidance for Spinal System
510(k)'s May 3, 2004 was performed for the THORTM 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]. The subject
THORTM system demonstrated equivalent material
biocompatibility and intended use as the Stryker Spine
CENTAUR Spinal System and the previously cleared THORTM
Anterior Plating System [510(k) K073437]. |
| ---------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2008
Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
Re: K080773
Trade/Device Name: THOR Anterior Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: March 17, 2008 Received: March 19, 2008
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.
5
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 M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Stryker Spine THORTM Anterior Plating System
Indications for Use
510(k) Number (if known): K 080773
Device Name: Stryker Spine THOR™ Anterior Plating System
Indications for Use:
When used as an anterior non-pedicle fixation system in the lumbar and lumbosacral spine (L1-S1), THOR Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels. 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 degenerative disc confirmed by history and radiographic studies);
-
- Pseudoarthrosis
-
- Spondylolysis
- Spondyloisthesis 4)
- Trauma (i.e. Fracture of Dislocation) 5)
- Deformities (i.e. Scoliosis or Lordosis) 6)
- Spinal Stenosis 7)
- Failed previous Fusion 8)
INDICATIONS CONTINUE ON NEXT PAGE
AND/OR 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 CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogle - for mkg
Division of General, Restora and Neurological Devices
Page 1 of 2
510(k) Number K080773
7
Traditional 510(k) Premarket Notification
Indications for Use (continued)
When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (T1-L5), THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skelefally 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 degenerative disc confirmed by history and radiographic studies)
-
- Trauma (i.e. Fracture or Dislocation)
-
- Spinal Stenosis
-
- Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis)
-
- Tumors
-
- Failed Previous Fusion