(29 days)
Not Found
Not Found
No
The 510(k) summary describes a physical implant device (vertebral body support system) and does not mention any software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The document describes a surgical implant intended to replace damaged vertebrae, which is a structural or supportive function, not a therapeutic intervention to treat a disease or condition in the way a therapeutic device typically would (e.g., drug delivery, stimulation, or ablation).
No
Explanation: The device is a vertebral body support system intended to replace a vertebral body or an entire vertebra. It is an implant for structural support, not a tool for diagnosing medical conditions.
No
The device description explicitly states it consists of a cage body and endcaps, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The provided text clearly describes a surgical implant intended to replace a vertebral body or entire vertebra within the thoracolumbar spine. This is a device that is surgically implanted inside the body.
The description focuses on the physical structure and surgical application of the device, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Stryker Spine Vertebral Body Support System implant is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (FI-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra due to tumor or trauma (i.e. fracture). For both corpectomy and vertebrectomy procedures, the Stryker Spine Vertebral Body Support System is intended to be used with supplemental internal spinal fixation systems. The use of bone graft with the Stryker Spine Vertebral Body Support System is optional.
Product codes
MQP
Device Description
This Special 510(k) submission is intended to address design modifications and a line extension to the predicate Surgical Dynamics Mesh Cage System to create the subject device that is referred to as the Stryker Spine Vertebral Body Support System. The Surgical Dynamics Mesh Cage System consists of a cage body and endcaps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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)
Performance data were submitted to characterize the additional components and design modifications to the Surgical Dynamics Mesh Cage System to create the subject Stryker Spine Vertebral Body Support System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN - 8 2004
Special 510(k) Summary of Safety and Effectiveness: Stryker Spine Vertebral Body Support System (Line Extension and Design Modification to the Surgical Dynamics Mesh Cage System)
| Proprietary Name: | Stryker Spine Vertebral Body Support System |
|---|---|
| Common Name: | Vertebral Body Replacement Device |
| Proposed Regulatory Class: | Class II |
| Spinal Intervertebral Body Fixation Orthosis, | |
| 21 CFR §888.3060 | |
| Device Product Code: | 87 MQP: Spinal Vertebral Body Replacement Device |
| For Information contact: | Karen Ariemma |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive, Mahwah, NJ 07430 | |
| Telephone: (201) 831-5718 | |
| Fax: (201) 831-6038 | |
| Email: kariemma@howost.com | |
| Date Summary Prepared: | December 9, 2003 |
This Special 510(k) submission is intended to address design modifications and a line extension to the predicate Surgical Dynamics Mesh Cage System to create the subject device that is referred to as the Stryker Spine Vertebral Body Support System. The Surgical Dynamics Mesh Cage System consists of a cage body and endcaps. There is no change in intended use for the modified device when compared to the previously cleared device.
Intended Use:
The Stryker Spine Vertebral Body Support System implant is a device intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (FI-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra due to tumor or trauma (i.e. fracture). For both corpectomy and vertebrectomy procedures, the Stryker Spine Vertebral Body Support System is intended to be used with supplemental internal spinal fixation systems. The use of bone graft with the Stryker Spine Vertebral Body Support System is optional.
Statement of Technological Comparison:
The subject components share the same intended use and basic design concepts as that of the predicate device. Performance data were submitted to characterize the additional components and design modifications to the Surgical Dynamics Mesh Cage System to create the subject Stryker Spine Vertebral Body Support System.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
JAN - 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430
K033837 Re:
Trade Name: Stryker Spine Vertebral Body Support System (VBOSS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 9, 2003 Received: December 10, 2003
Dear Ms. Ariemma:
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 cnactment 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Karen Ariemma
This letter will allow you to begin marketing your device as described in your Section 510(k) previous This letter will allow you to begin marketing your device to a legally marketed predicate
notification. The FDA finding of substantial equivalence of your dovice to a begall notification. The FDA Inding of substantial equivalience of 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 on the the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misformating on the Office of Compliance at (301) 394-4039. Also, production of the general information on reference to premarket notification (21ct K Pair of Small Manufacturers, International and your responsibilities under the Acchibit the Division of SinLiver (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
yours,
le N. Milker
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
3
510(k) Number (if known): K033837
Device Name: Stryker Spine Vertebral Body Support System
The Stryker Spine Vertebral Body Support System implant is a device intended to replace a The buyker Spine Vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a vellapsed, damaged, or unstable vertebral body or vertebra due to tumor or trauma (i.e. fracture). contipou, and vertebrectomy procedures, the Stryker Spine Vertebral Body Support System is intended to be used with supplemental internal spinal fixation systems. The use of bone graft with the Stryker Spine Vertebral Body Support System is optional.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-The-Counter Use _ (Per 21 CFR 801.109)
the (Optional Format 1-2-96)
for Mark N Mella
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices