# K974435: Michelson Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 19, 1998 after 87 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
71 later devices descend from it; 2 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ORION Anterior Cervical Plate: named in the summary without a submission number
- (no number) Synthes CSLP System: named in the summary without a submission number

## Most influential descendants
- K012305: Modification to: Trinica Anterior Cervical Plate System (2001), 70 descendants of its own
- K022344: Trinica Select Anterior Cervical Plate System (2002), 43 descendants of its own
- K120515: Tempus Cervical Plate System (2012), 23 descendants of its own
- K132012: Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate System (2013), 22 descendants of its own
- K131374: Tempus (TM) Cervical Plate System (2013), 22 descendants of its own

## Indications for use
The Michelson Anterior Cervical Plate System is intended to provide stability while allowing the cervical spine to fuse for the following indications: Instability caused by trauma (including fractures); Instability associated with correction of cervical lordosis, scoliosis and kyphosis deformity; Instability associated with tumors; Instability associated with degenerative disk diseases defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; Instability from failed previous fusions. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K974435
Methodology: https://510kreport.com/methodology