# K963288: LM Bone Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Li Medical Technologies, Inc.
- Decided: Nov 13, 1996 after 84 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.
No later device cites it as a predicate yet.
0 of 12 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). Our OCR of the scanned summary read K931472, FDA’s number for Careject Disposable Syringe and Needle (Carewell Mediproducts, Ltd.). Corrected to the only number one digit away that is an earlier device of this one’s maker, Li Medical Technologies, Inc., in this field.
- 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). Our OCR of the scanned summary read K960823, FDA’s number for Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent (Dentsply Intl.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “L1 Medical Bone Anchor”.

## Indications for use
Bladder neck suspension for female urinary incontinence due to urethral hypermobility. Fixation in pubic bone for the purpose of bladder neck suspension using USP #2 Class I, non-absorbable, synthetic suture (e.g., polypropylene). A minimum of two LM Anchors should be used in this (modified MMK, Raz, or Stamey, i.e., Benderev) procedure.

Source page: https://510kreport.com/device/K963288
Methodology: https://510kreport.com/methodology