(59 days)
Not Found
No
The summary describes a mechanical vertebral body replacement device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device replaces a collapsed, damaged, or unstable vertebral body and provides anterior spinal column support, which are therapeutic actions.
No
Explanation: The device is described as a "vertebral body replacement device" intended to provide structural support and stability in the spine after a corpectomy, which is a surgical procedure. It is a surgical implant, not a tool used for diagnosis.
No
The device description clearly describes a physical implantable device made of radiolucent and radiopaque materials, with screws and a plate, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided text, the SynFixTM-LR is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The SynFixTM-LR is a physical implantable device intended to replace a vertebral body in the spine. It is a surgical device used in the body, not a device used to test samples from the body.
The description clearly outlines its use as a structural support device for the spine following surgery, which is the function of a medical device, not an IVD.
N/A
Intended Use / Indications for Use
The SynFixTM-LR is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedure due to tumor or trauma (i.e., fracture). The SynFixTM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer component of the SynFixTM-LR can be packed with bone (autograft or allograft).
SynFixTM-LR is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The Synthes SynfixTM-LR is a combination radiolucent and radiopaque vertebral body replacement device to provide structural stability in skeletally mature individuals following corpectomy.
The SynfixTM-LR may be used to accommodate the anatomical requirements of the space created by the corpectomy. Four screws are inserted through the anteriorly located plate into the neighboring vertebral bodies and lock securely to the plate using a tapered thread locking mechanism. The SynFixTM-LR is intended to be used with Synthes supplemental internal fixation systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of the spacer has openings that can be packed with bone (autograft or allograft).
The SynfixTM-LR is available as assembled components in various heights and geometrics to suit the individual pathology and anatomical conditions.
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
skeletally mature individuals
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)
Not Found
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.
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
FEB 1 3 2006
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Contact: | Angela Mikroulis, R.A.C.
Regulatory Affairs Project Manager
Phone: (610) 719-5718
Fax: (610) 719-5102 |
| Trade Name: | SynFixTM-LR |
| Date Prepared: | November 30, 2005 |
| Common / Classification Name: | Spinal intervertebral body fixation orthosis |
| Device Product Code and Classification: | MQP
21 CFR 888.3060
Class II |
| Predicate: | K011037- Synthes Vertebral Spacer
K050624- Stryker Spine AVSTM PL PEEK Spacer |
| Device Description: | The Synthes SynfixTM-LR is a combination radiolucent and
radiopaque vertebral body replacement device to provide
structural stability in skeletally mature individuals following
corpectomy.
The SynfixTM-LR may be used to accommodate the anatomical
requirements of the space created by the corpectomy. Four
screws are inserted through the anteriorly located plate into the
neighboring vertebral bodies and lock securely to the plate using
a tapered thread locking mechanism. The SynFixTM-LR is
intended to be used with Synthes supplemental internal fixation
systems, e.g. ATLP, TSLP, VentroFix or USS. The interior of
the spacer has openings that can be packed with bone (autograft
or allograft).
The SynfixTM-LR is available as assembled components in
various heights and geometrics to suit the individual pathology
and anatomical conditions. |
| Intended Use/ Indications for Use: | The SynFixTM-LR is a vertebral body replacement device
intended for use in the thoracolumbar spine (T1-L5) to replace a
collapsed, damaged, or unstable vertebral body resected or
excised during partial and total vertebrectomy procedure due to
tumor or trauma (i.e., fracture). The SynFixTM-LR is intended to
be used with Synthes supplemental internal fixation systems, e.g.
ATLP, TSLP, VentroFix or USS. The interior of the spacer
component of the SynFixTM-LR can be packed with bone
(autograft or allograft).
SynFixTM-LR is designed to provide anterior spinal column |
510 (k) Summary
.
1
| Substantial Equivalence: | Documentation has been provided that demonstrates that the SynFix TM -LR device is substantially equivalent (SE) to the previously cleared vertebral replacement device (K011037). |
|---|---|
| -------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing the bird's body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2006
Angela Mikroulis, R.A.C. Regulatory Affairs Project Manager Synthes Spine Co. L.P. 1302 Wrights Lane East West Chester, PA 19380
Re: K053508
Trade/Device Name: SynFix™-LR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: December 15, 2005 Received: December 16, 2005
Dear Ms. Mikroulis:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bector 3 rQxy press. Is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tise stated in the encrosule) to regally manation posice Americal Device American be on the only Food. Dava commerce prior to May 20, 1970, the enavations of the Federal Food. Drug. devices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the dovrees, soojeet to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller "Entroling may of the 898. In addition, FDA may oc found in the Out or events concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination and of the Ad Please be advised that I DA s issuation of a because of a benefits with other requirements of the Act that IDA has made a decornmancer an administered by other Federal agencies. You must or any Federal statutes and regulations annuding, but not limited to: registration and listing (21 Colliply with an the Act 3 requirements, moraans, 2017, 2011, 2011 manufacturing practice requirements as set
3
Page 2 – Ms. Angela Mikroulis
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) regalates) (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-105 product radiation control provisions (Doctoris 991 - vice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device to and suice to Jogo I his letter will anow you to begin makemig your antial equivalence of your device to a legally premarket notification. The PDA miding of backantal equate and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your device on our case note the regulation entitled, the more a bissing Conlier the Office of Compliance at (210) 216 - 16 - 16 - 16 - 10 - 10 - 10 - 16 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -" Misbranding by relevence to premantee noulities. In the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Fibersity of Carbider Station of Support/index.html.
Sincerely yours,
So Mark N. Melkerson
Acting Director
Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): Kx(x3 3 SOS
Device Name: SynFixTM-LR
Indications for Use:
The SynFix™-LR is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised Spine (11 25) to replal vertebrectoniy procedure due to tumor or trauma (i.e., fracture). The SynFix™-LR is intended to be used with Synthes supplemental internal fixation systems, org. ATLP, TSLP, Ventrolix or USS. The interior of the spacer component of the SynFix™-LR can be packed with bone (autograft or allograft).
SynFix™-LR is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of a
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(Division Sign-Off) (Division Sign-Onal Restorative, Division of Ogical Devices
510(k) Number_