(68 days)
Not Found
Not Found
No
The provided text describes a physical medical device (vertebral body replacement) and its intended use, without any mention of software, algorithms, image processing, AI, ML, or related concepts.
Yes
The device is indicated for the replacement, partial vertebrectomy, and/or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma, leading to the restoration of planar alignment, height, and facilitating neural decompression. These actions directly address a medical condition and restore function, classifying it as a therapeutic device.
No
The device is described as a vertebral body replacement or partial replacement, intended to restore biomechanical integrity after destruction by tumor or fracture/trauma. It is a therapy rather than a diagnostic tool.
No
The device description clearly states it is a "radiolucent vertebral body replacement device used in conjunction with cancellous bone screws," indicating it is a physical implant, not software.
Based on the provided information, the STALIF™ TT 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, or tissue) to provide information about a person's health.
- STALIF™ TT Function: The description clearly states the STALIF™ TT is a vertebral body replacement device used in surgery to restore the spine's structure and biomechanical integrity. It is implanted directly into the body.
The intended use and device description focus on a surgical implant for structural support, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in the thoracolumbar spine (from T9 to L5). The STALIF™ TT device may be used with bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The Surgicraft STALIF™ TT is a radiolucent vertebral body replacement device used in coniunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic (T9 to T12), lumbar spine (L1 to L5), thoracolumbar spine (from T9 to 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 provided.
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.
DePuy AcroMed Stackable Cage™ System, Interpore Cross International GEO Structure
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
JUN 2 9 2005
PREMARKET NOTIFICATION 510(K) SUMMARY
STALIF TT™ SYSTEM
| Company: | Surgicraft, LTD
8 Padgets Lane
South Moons Moat
Redditch, United Kingdom
B98 ORA |
| ---------- | ---------------------------------------------------------------------------------------------- |
|---|
Steve Trotman Contact:
Proposed Proprietary Trade Name:
STALIF™ TT
888.3060 Orthopedics Classification Name:
FDA Product Code MQP, Class II Classification:
Device Description:
The Surgicraft STALIF™ TT is a radiolucent vertebral body replacement device used in coniunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion.
Material:
PEEK-OPTIMA LT1
Intended Use:
The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in the thoracolumbar spine (from T9 to L5). The STALIF™ TT device may be used with bone graft.
| Predicate Device: | DePuy AcroMed Stackable Cage™ System
Interpore Cross International GEO Structure |
|--------------------------|-------------------------------------------------------------------------------------|
| Substantial Equivalence: | Performance data were provided. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The emblem is positioned to the right of the text and is a prominent element of the logo.
Public Health Service
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Surgicraft L.T. D. C/o Ms. Janet M. Webb MEDVantage Incorporated 950 N. Michigan Avenue #2202 Chicago, Illinois 60611
Re: K051027
Trade/Device Name: STALIF TT Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 13, 2005 Received: June 14, 2005
Dear Ms. Webb:
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.
2
Page 2 - Ms. Janet M. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter with and yourse 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,
A. Styet Rhodes
C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): K051027 Device Name: STALIF TT TM Indications for Use:
The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in device is intendou for Good a Torestial book ropacement of partice may be used with bone graft.
or Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________ Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hypt. Durden
(Divisio Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________