(230 days)
Not Found
No
The summary describes a purely mechanical fixation system (plates and screws) and makes no mention of AI or ML technology.
Yes.
The device is intended to hold or buttress an allograft to prevent its expulsion or impingement on the spinal cord after a laminoplasty, thereby providing a therapeutic benefit by addressing a medical condition.
No
The device is described as a fixation system used to hold or buttress allografts in place in the spine, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is comprised of physical components (mini-plates and screws made of titanium) intended for surgical implantation.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (plates and screws) used to fix bone in the spine after a specific surgical procedure (laminoplasty). It is a physical device implanted in the body, not a test performed on a sample outside the body.
The description focuses on the materials, design, and surgical application of the device, which are characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Synthes Arch™ Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Arch™ Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
Product codes
NQW
Device Description
The Synthes AFS is comprised of various sized, pre-bent mini-plates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at the center and both ends of the plate to allow for attachment to the bone. The center hole in the plate is used for attachment to bone allograft. The plates are composed of commercially pure titanium which conforms to ASTM F67.
The screws intended for use with the mini-plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements. The screws are composed of titanium alloy, Ti6Al7Nb, which conforms to ASTM F1295.
The Synthes AFS is designed to be used in conjunction with the components that comprise previously cleared Synthes posterior cervical spine products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3-T3)
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 characteristics comparing the Synthes AFS to performance characteristics of commercially available devices were provided to support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K963741, K961485, K961497, K850631
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
APR = 1 2004
3.0 Summary of Safety and Effectiveness Information
| SPONSOR: | Synthes USA
1230 Wilson Drive
West Chester, PA 19380
(484) 356-9614
Contact: Susan Lewandowski |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes Arch™ Fixation System (AFS) |
| CLASSIFICATION: | 21 CFR §888.3050: Spinal interlaminal fixation orthosis.
Product code: NQW |
| COMMON NAME: | Appliance, fixation, interlaminal |
| PREDICATE DEVICE: | Plate, fixation, bone:
K963741 – Howmedica Leibinger Inc.
K961485 – Howmedica Inc.
K961497 – Howmedica Inc.
Bone fixation Cerclage:
K850631 – Kirschner Medical Corp. |
| DEVICE DESCRIPTION: | The Synthes AFS is comprised of various sized, pre-bent mini-
plates that are designed to fit the anatomy of the vertebral arch
(i.e., between the pedicle and spinous process). The plates
have screw holes located at the center and both ends of the
plate to allow for attachment to the bone. The center hole in
the plate is used for attachment to bone allograft. The plates
are composed of commercially pure titanium which conforms to
ASTM F67.
The screws intended for use with the mini-plates are available
in a variety of lengths and diameter and are designed to match
the anatomical requirements. The screws are composed of
titanium alloy, Ti6Al7Nb, which conforms to ASTM F1295.
The Synthes AFS is designed to be used in conjunction with
the components that comprise previously cleared Synthes
posterior cervical spine products. |
| INTENDED USE: | The Synthes AFS is indicated for use in the lower cervical and
upper thoracic spine (C3-T3) after a laminoplasty has been
performed. The Arch Fixation System holds or buttresses the |
1
K032534
Page 2 of 2
The first to the country of the complement of the former of the form and
allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
- All components of the Synthes AFS are manufactured from MATERIAL: commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295).
PERFORMANCE Performance characteristics comparing the Synthes AFS to DATA: performance characteristics of commercially available devices were provided to support a determination of substantial equivalence.
The Synthes AFS implants are similar in design, material and BASIS OF performance to currently marketed orthopedic implants. The SUBSTANTIAL EQUIVALENCE: intended use of the product as a buttress plate is substantially equivalent to information presented on the predicate device.
Company of the program and the many of the program and the may be will be and
The For the may be the will and the same and a send a send
2
Image /page/2/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 three stylized human figures or profiles facing to the right, stacked on top of each other. The figures are depicted in a way that suggests movement or flow.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 1 2004
Ms. Susan Lewandowski Project Manager, Regulatory Affairs Synthes (USA) 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K032534
Trade/Device Name: Synthes Arch™ Fixation System (AFS) Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NOW Dated: January 2, 2004 Received: January 5, 2004
Dear Ms. Lewandowski:
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
3
Page 2 - Ms. Susan Lewandowski
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. 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsma/dsmamain.html
Sincerely yours.
Mark A. Milken
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
4
Indications for Use Statement 2.0
Page 1 of 1
510(k) Number (if known): __ _________________________________________________________________________________________________________________________________________________
Synthes Arch™ Fixation System (AFS) Device Name:
Indications:
The Synthes Arch™ Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Arch™ Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
R. Mark N. Milliman
Division of General. Restorative. and Neurological Devices
510(k) Number K032534