(26 days)
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No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as "intended for the temporary stabilization of the anterior spine during the development of cervical spinal fusions," which is a therapeutic intervention for various spinal conditions.
No
The device is described as an Anterior Cervical System consisting of bone plates and screws for stabilization during spinal fusions, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states that the system consists of "a variety of bone plates and screws," which are physical hardware components intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that this system is for "anterior interbody screw/plate fixation of the cervical spine" and is used for "temporary stabilization of the anterior spine during the development of cervical spinal fusions." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device is described as "a variety of bone plates and screws" designed for insertion into vertebral bodies. This is consistent with a surgical implant.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens outside the body.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
KWQ
Device Description
The ZEPHIR™ Anterior Cervical System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The ZEPHIR™ Plates include anti-migration caps that cover the heads of the bone screws to reduce the potential for screw back-out. The anti-migration caps come pre-assembled to the plate.
The purpose of this submission is to add additional screws to the Zephir™ Anterior
Cervical System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine, anterior spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Documentation was provided which demonstrated the Zephir™ Anterior Cervical System to be substantially equivalent to itself.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K030327 p'/1
ZephirTM Anterior Cervical System 510(k) Summary January 2003
FEB 2 6 2003
- Medtronic Sofamor Danek I. Company: 1800 Pvramid Place Memphis, TN 38132 (901) 396-3133
Proprietary Trade Name: Zephir™ Anterior Cervical System II.
Regulation Number: 888.3060 - KWQ III.
IV. Product Description
The ZEPHIR™ Anterior Cervical System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The ZEPHIR™ Plates include anti-migration caps that cover the heads of the bone screws to reduce the potential for screw back-out. The anti-migration caps come pre-assembled to the plate.
The purpose of this submission is to add additional screws to the Zephir™ Anterior
Cervical System.
V. Indications
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Substantial Equivalence VI.
Documentation was provided which demonstrated the Zephir™ Anterior Cervical System to be substantially equivalent to itself.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
FEB 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132
Re: K030327
Trade/Device Name: Zephir™ Anterior Cervical System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: January 29, 2003 Received: January 31, 2003
Dear Dr. Treharne:
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. Iisting 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 - Richard W. Treharne, Ph.D.
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) 594-4639. 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_KG36)27
Device Name: ZEPHIR™ Anterior Cervical System
Indications for Use:
Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.
Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.
This device is not approved for screw attachment to the posterior elements WARNING: (pedicles) of the cervical, thoracic, or lumbar spine.
f Mark N Milkersen
Division Sig
Division of G l. Restorative
and Neurologic Devices
k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)
OR
Over-the-counter Use