# K981755: LM Anchor

- Pathway: 510(k) (Abbreviated)
- Applicant: Li Medical Technologies, Inc.
- Decided: Jul 13, 1998 after 56 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: 1 generation back to K915889 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915889: Mitek Bone Anchor, Modification, Mitek Surgical Products, Inc. (1992) Summary page 1.

## Indications for use
Shoulder - bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction Hand/wrist - ulnar or lateral collateral ligament reconstruction, radial collateral ligament, scapholunate ligament reconstruction Foot/ankle - hallux valgus reconstruction, midfoot reconstructions, lateral stabilization, medial stabilization, achilles tendon Elbow - biceps tendon, ulnar collateral ligament, radial collateral ligament Knee - medial collateral ligament, lateral collateral ligament, patellar tendon, patellar ligament avulsions, posterior oblique ligament, joint capsule to tibia, iliotibial band tenodesis

Source page: https://510kreport.com/device/K981755
Methodology: https://510kreport.com/methodology