# K960825: LM Anchor or Other Proprietary Name

- Pathway: 510(k) (Traditional)
- Applicant: Li Medical Technologies, Inc.
- Decided: Apr 30, 1996 after 61 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 K920213 (1992). 2 ancestors in all.
61 later devices descend from it; 3 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920213: Mitek Anchor, Mitek Anchor II, Mitek Surgical Products, Inc. (1992) Summary page 1.
- K951233: LMT Bone Anchor, Li Medical Technologies, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K915839: Mitek Surgical Products GII Anchor. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K963812: LM Bone Anchor (Orthopedics) (1996), 58 descendants of its own
- 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

## Indications for use
Shoulder (bankart repair, rotator cuff repair, SLAP lesion, acromio-clavicular separation, biceps tenodesis, deltoid repair, capsular shift reconstruction, capsulolabral reconstruction), Hand/Wrnst (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, tennis elbow, 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), Bladder Neck Suspension.

Source page: https://510kreport.com/device/K960825
Methodology: https://510kreport.com/methodology