# K970048: Synthes (Usa)Titanium Locking Plate System (Tilps)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 1, 1997 after 207 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
Longest line of descent: 1 generation back to K926453 (1993). 3 ancestors in all.
54 later devices descend from it; 7 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 1.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 1.
- K925351: Synthes (U.S.a.) Anterior Spinal Plate, Synthes (Usa) (1993) Summary page 1.

## Most influential descendants
- K010466: Tether Acfs (2001), 43 descendants of its own
- K121514: Anodyne Anterior Cervical Plate System (2012), 21 descendants of its own
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K040003: Vertebron SCP Cervical Plate System (2004), 12 descendants of its own

## Indications for use
The Synthes TiLPS is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervetebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease. DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies

Source page: https://510kreport.com/device/K970048
Methodology: https://510kreport.com/methodology