# K981452: Osteonics Long Arm Containment Ring

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: May 20, 1998 after 28 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Osteonics® Spinal System Low Profile Cap: named in the summary without a submission number

## Most influential descendants
- K990158: Osteonics Combination Screw Ring/Blocker (1999), 1 descendant of its own
- K020293: Osteonics Spinal System (2002), 0 descendants of its own

## Indications for use
The uses for the Osteonics® Long Arm Containment Ring, as part of the legally marketed Osteonics® Spinal System, are as follows: Non-Pedicular Use; fixation of the T4-S2 spine: . Long and short curve scoliosis . Vetebral fracture or dislocation . Spondylolisthesis . Degenérative disc disease (defined as back pain of discogeric origin with degeneration of the disc confirmed by history and radiographic studies). . Previously faiied fusion . Spinal tumor Pedicular Use: . When used as a pedicle screw system, the system is intended for patients: (a) having severe spendylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Pedicle screws are not intended for placement in pedicles above L3.

Source page: https://510kreport.com/device/K981452
Methodology: https://510kreport.com/methodology