# K963812: LM Bone Anchor (Orthopedics)

- Pathway: 510(k) (Traditional)
- Applicant: Li Medical Technologies, Inc.
- Decided: Nov 12, 1996 after 64 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: 2 generations back to K921873 (1992). 11 ancestors in all.
58 later devices descend from it; 2 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904436: Quickanchor (TM), Mitek Surgical Products, Inc. (1990) Summary page 1.
- K951233: LMT Bone Anchor, Li Medical Technologies, Inc. (1995) Summary page 1.
- K951472: LMT Bone Anchor, Li Medical Technologies, Inc. (1995) Summary page 1.
- K953764: LMT Bone Anchor, Li Medical Technologies, Inc. (1995) Summary page 1.
- K960448: LM Anchor, Li Medical Technologies, Inc. (1996) Summary page 1.
- K960439: LM Bone Anchor, Li Medical Technologies, Inc. (1996) Summary page 1.
- K960825: LM Anchor or Other Proprietary Name, Li Medical Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own
- K111779: Y-Knot All-Suture Anchor Model HF13 (2011), 29 descendants of its own
- K131035: Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM (2013), 17 descendants of its own
- K133224: Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi Sutures (2014), 12 descendants of its own
- K163258: CrossFT Knotless Suture Anchor with Disposable Driver (2017), 9 descendants of its own

## Indications for use
Shoulder (rotator cuff repair) 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) Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodws 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, ihotibial band tenodesis).

Source page: https://510kreport.com/device/K963812
Methodology: https://510kreport.com/methodology