510(k) · Cleared
ClearedLM Bone Anchor (Orthopedics)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Li Medical Technologies, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 12, 1996 as substantially equivalent to K904436 (Mitek Surgical Products, Inc., 1990) and 6 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1992. 58 later devices descend from it.
- Decided
- Nov 12, 1996
- Review
- 64 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K921873 (1992). 11 ancestors in all, the oldest K904436 (1990). 58 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 1 generation backK960448 LM AnchorLi Medical Technologies, Inc. · 1996
- This deviceK963812 LM Bone Anchor (Orthopedics)Li Medical Technologies, Inc. · 1996
- Descendant · cites it directly · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- Descendant · 2 generations on · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- Descendant · 3 generations on · 17 of its ownK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- Descendant · 4 generations on · 12 of its ownK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014
- Descendant · 2 generations on · 9 of its ownK163258 CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation · 2017
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · cites it directly56descendants
- K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · 2 generations on29descendants
- K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 3 generations on17descendants
- K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation · 2014 · 4 generations on12descendants
- K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation · 2017 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −1 | K960448 | LM Anchor | Li Medical Technologies, Inc. | 1996 | — |
| 0 (this device) | K963812 | LM Bone Anchor (Orthopedics) | Li Medical Technologies, Inc. | 1996 | — |
| +1 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| +2 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| +3 | K131035 | Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM | Linvatec Corporation D/B/A Conmed Linvatec | 2013 | — |
| +4 | K133224 | Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2… | Conmed Corporation | 2014 | — |
| +2 | K163258 | CrossFT Knotless Suture Anchor with Disposable Driver | Conmed Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K904436 | Quickanchor (TM)Summary page 1…hodemann Li, Vice President October 30, 1996 Staple, Fixation, Bone Bone anchor LM Anchor Products or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) Li Medical Bone Anchor (K951233), (K951472), (K953764), (K960448), (K960439), (K960825) Made from surgical grade stainless stee… | 1990 |
| * | K951233 | LMT Bone AnchorSummary page 1…ber 30, 1996 Staple, Fixation, Bone Bone anchor LM Anchor Products or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) Li Medical Bone Anchor (K951233), (K951472), (K953764), (K960448), (K960439), (K960825) Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI)… | 1995 |
| * | K951472 | LMT Bone AnchorSummary page 1…6 Staple, Fixation, Bone Bone anchor LM Anchor Products or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) Li Medical Bone Anchor (K951233), (K951472), (K953764), (K960448), (K960439), (K960825) Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM An… | 1995 |
| * | K953764 | LMT Bone AnchorSummary page 1…Fixation, Bone Bone anchor LM Anchor Products or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) Li Medical Bone Anchor (K951233), (K951472), (K953764), (K960448), (K960439), (K960825) Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Produc… | 1995 |
| * | K960448 | LM AnchorSummary page 1…one Bone anchor LM Anchor Products or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) Li Medical Bone Anchor (K951233), (K951472), (K953764), (K960448), (K960439), (K960825) Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are desi… | 1996 |
| * | K960439 | LM Bone AnchorSummary page 1…chor LM Anchor Products or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) Li Medical Bone Anchor (K951233), (K951472), (K953764), (K960448), (K960439), (K960825) Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are designed with a… | 1996 |
| * | K960825 | LM Anchor or Other Proprietary NameSummary page 1…hor Products or other proprietary names Mitek Surgical Products GII QuickAnchor (K904436) Li Medical Bone Anchor (K951233), (K951472), (K953764), (K960448), (K960439), (K960825) Made from surgical grade stainless steel (316L) or titanium (6A1-4V ELI), the LM Anchor Products are designed with a crown and… | 1996 |
What descends from it? (58)
See all 582 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K091549 (Linvatec Corp., 2009) has gone furthest, with 56 descendants of its own.
- 4 other devices also cite its predicate K904436.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
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…
Read the full statement (113 words)
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963812 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963812: LM Bone Anchor (Orthopedics).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963812
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026