(85 days)
Not Found
No
The summary describes a physical vertebral body replacement device made of PEEK material, intended for surgical implantation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is indicated for replacement, partial vertebrectomy, and/or augmentation of a vertebral body due to destruction by tumor or fracture, which are medical treatments.
No
This device is a vertebral body replacement device, intended for surgical implantation to restore mechanical support to the spine after a vertebral body has been removed or damaged. It does not perform any diagnostic function.
No
The device description clearly states it is a "radiolucent vertebral body replacement device" made of PEEK-OPTIMA LT1, which is a physical implant, not software.
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.
- STALIF™ TT Function: The STALIF™ TT device is a surgical implant designed to replace or augment a vertebral body in the spine. It is a physical device used within the body during surgery, not a tool for analyzing samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for spinal reconstruction due to tumor or fracture, not a diagnostic test.
- Device Description: The description details a radiolucent vertebral body replacement device made of PEEK-OPTIMA LT1, which is consistent with a surgical implant.
The information provided describes a surgical implant used for structural support in the spine, which falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STALIF™ TT device is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).
The STALIF™ TT device is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the STALIF™ TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).
The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).
The STALIF ™ TT device is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).
Product codes
MQP
Device Description
- The Surgicraft STALIFTM TT is a radiolucent vertebral body replacement device used in conjunction 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic (T9 to T12) and 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 submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
14/6/7
PREMARKET NOTIFICATION 510(K) SUMMARY
STALIF TT™ SYSTEM
Company: Surgicraft 16 The Oaks, Clews Road Redditch, Worcestershire United Kingdom B98 7ST
Steve Trotman Contact:
Proposed Proprietary Trade Name:
STALIF™ TT
Classification Name: 888.3060 Orthopedics
FDA Product Code Classification:
MQP
- The Surgicraft STALIFTM TT is a radiolucent vertebral Device Description: body replacement device used in conjunction 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 use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).
The STALIF™ TT device is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the STALIF™ TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).
| Predicate Device: | DePuy AcroMed Stackable Cage™ System
K990148, K001340, K013382 |
| ------------------- | ------------------------------------------------------------------- |
|---|
Performance Data: Performance data were submitted.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Surgicraft Ltd. c/o Ms. Janet M. Webb Medvantage Inc. 121 W. Chestnut Street, #3506 Chicago, IL 60610
Re: K041617 Trade/Device Name: STALIF TT Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral body replacement device Regulatory Class: Class II Product Code: MQP Dated: June 2, 2004 Received: June 15, 2004
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 Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to oegin maine of substantial equivalence of your device to a legally premarked notification: "The PDF Intelling of bevice 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 If you ucare specific advice for your act (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain Whisbiananing by reference to presences ibilities under the Act from the Division of Small other general 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/dsma/dsmamain.html
Sincerely yours,
Mark N. Milkersen
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
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Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known): K041617 Device Name: STALIF TT Indications for Use:
The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5).
The STALIF ™ TT device is intended for use with supplemental internal fixation.
The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).
Prescription Use _ _ X Over-The-Counter Use or
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkerson
Division of General, Restorative, and Neurological Devices
510(k) Number K041617