510(k) · Cleared
ClearedBio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Oct 21, 1998 as substantially equivalent to K964805 (Linvatec Corp., 1997) and 2 other predicates after a 40-day review. Its family tree reaches back 2 generations to 1993. 80 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 40 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K926384 (1993). 6 ancestors in all. 80 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK926384 Statak & Mini-Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1993
- 1 generation backK963369 Bio-AnchorLinvatec Corp. · 1997
- This deviceK983186 Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorLinvatec Corp. · 1998
- Descendant · cites it directly · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- Descendant · cites it directly · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- Descendant · 2 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- Descendant · 2 generations on · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- Descendant · 3 generations on · 56 of its ownK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · cites it directly78descendants
- K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · cites it directly77descendants
- K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd. · 2004 · 2 generations on76descendants
- K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · 2 generations on75descendants
- K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · 3 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926384 | Statak & Mini-Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1993 | — |
| −1 | K963369 | Bio-Anchor | Linvatec Corp. | 1997 | — |
| 0 (this device) | K983186 | Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor | Linvatec Corp. | 1998 | — |
| +1 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| +1 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| +2 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| +2 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| +3 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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? (3)
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 |
|---|---|---|---|
| * | K964805 | Bio-AnchorSummary page 4…cid SIMILARITIES AND DISSIMILARITIES Single-Usc ETO Sterilization Shipped Sterile Anchor: Suture: 3.5mm x 10. 5nem USP Size #2 FREDICATE Linvatec Bio-Anchor 510(k) #K964805 #K963369 Bio-Anchor Soft tissue to bone fixation for shoulder, knee, foot, ankle, elbow, wrist, hand, and bladder neck suspensi… | 1997 |
| * | K963369 | Bio-AnchorSummary page 4…LARITIES AND DISSIMILARITIES Single-Usc ETO Sterilization Shipped Sterile Anchor: Suture: 3.5mm x 10. 5nem USP Size #2 FREDICATE Linvatec Bio-Anchor 510(k) #K964805 #K963369 Bio-Anchor Soft tissue to bone fixation for shoulder, knee, foot, ankle, elbow, wrist, hand, and bladder neck suspension proced… | 1997 |
| * | K953954 | Preloaded Soft Tissue AnchorSummary page 4…suspension procedures . Poly (L-lactic)acid Single-Use ETO Sterilization Shipped Sterile 3.5mm x 10.S5mm PREDICATE Linvatec Pre~loaded Soft Tissue Anchors 510 (%) AK953954 Revo/Mini Revo Soft tissue to bone fixation. Anchor: Titanium Alloy Suture: Mon-absorbable braided polyester Suture Sleeve: F… | 1996 |
What descends from it? (80)
See all 803 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 5 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K020056 (Bionx Implants, Ltd., 2002) has gone furthest, with 78 descendants of its own.
- 2 other devices also cite its predicate K964805.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications: Shoulder Bankart lesion repairs SLAP lesion repairs Acromio-clavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Altoid repairs Foot and Ankle 1. Hallux Valgus repairs 2. Medial or lateral instability…
Read the full statement (160 words)
The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:
Shoulder
Bankart lesion repairs
SLAP lesion repairs
Acromio-clavicular separation repairs
Rotator cuff tear repairs
Capsular shift or capsulolabral reconstructions
Biceps tenodesis
Altoid repairs
Foot and Ankle
1. Hallux Valgus repairs
2. Medial or lateral instability repairs/reconstructions
3. Achilles tendon repairs/reconstructions
4. Midfoot reconstructions
Elbow, Wrist and Hand
1. Scapholunate ligament reconstructions
2. Ulnar or radial collateral ligament reconstructions
3. Tennis elbow repair
4. Biceps tendon reattachment
Knee
1. Extracapsular repairs and reattachments of:
a. medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament or joint capsule to tibia
d. joint capsule closure to anterior proximal tibia
Extracapsular reconstruction, Iliotibial band tenodesis
Patellar realignment and tendon repairs
Bladder Neck Suspension
1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.
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/K983186 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983186: Bio-Anchor, Pre-Loaded Bioabsorbable Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983186
Report an extraction error
Are you the manufacturer?
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