# K990095: Straight-in-Orthopedic Bone Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Influence, Inc.
- Decided: Feb 1, 1999 after 20 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K920213 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982155: Short Straight-in Bone Screw Fixation System, Influence, Inc. (1998) Summary page 1.
- K971282: Anchorlok and Anchorlok RL Soft Tissue Anchor System, Wrightmedicaltechnologyinc (1997) Summary page 1.

## Indications for use
The Straight-In - Orthopedic Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures. It is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as: 1. Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction. 2. Repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation. 3. Repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament. 4. Repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis. 5. Repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.

Source page: https://510kreport.com/device/K990095
Methodology: https://510kreport.com/methodology