510(k) · Cleared
Recalled · Class II · 2019Peba Anchor/Suture Combination
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopaedic Biosystems, Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 6, 1998 after a 228-day review. The FDA summary names its predicate without a number. 488 later devices descend from it. It has been recalled once.
- Decided
- Feb 6, 1998
- Review
- 228 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 1
- Predicates
- 0
488 later devices descend from it, 9 citing it directly.
- This deviceK972326 Peba Anchor/Suture CombinationOrthopaedic Biosystems, Ltd. · 1998
- Descendant · cites it directly · 477 of its ownK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- Descendant · 2 generations on · 283 of its ownK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- Descendant · 3 generations on · 227 of its ownK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- Descendant · 2 generations on · 162 of its ownK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- Descendant · 4 generations on · 159 of its ownK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
Showing 5 of 488 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 488 · See all- K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSmith & Nephew, Inc. · 2006 · cites it directly477descendants
- K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006 · 2 generations on283descendants
- K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2007 · 3 generations on227descendants
- K061154Kinsa Suture AnchorSmith & Nephew, Inc. · 2006 · 2 generations on162descendants
- K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2009 · 4 generations on159descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972326 | Peba Anchor/Suture Combination | Orthopaedic Biosystems, Ltd. | 1998 | — |
| +1 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| +2 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| +3 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| +2 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| +4 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 10 | 0 |
| 2008 | 7 | 0 |
| 2009 | 15 | 0 |
| 2010 | 14 | 0 |
| 2011 | 27 | 0 |
| 2012 | 16 | 0 |
| 2013 | 28 | 0 |
| 2014 | 30 | 0 |
| 2015 | 22 | 0 |
| 2016 | 14 | 0 |
| 2017 | 19 | 0 |
| 2018 | 23 | 0 |
| 2019 | 26 | 0 |
| 2020 | 38 | 0 |
| 2021 | 22 | 0 |
| 2022 | 22 | 0 |
| 2023 | 50 | 0 |
| 2024 | 29 | 0 |
| 2025 | 33 | 0 |
| 2026 | 32 | 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? (2)
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 |
|---|---|---|---|
| * | — | Zimmer Statak 2.5 Anchor Named without a submission number | |
| * | — | Arthrex Corkscrew 5.0 mm Anchor Named without a submission number |
What descends from it? (488)
See all 4889 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor | 2006 | 477 |
| K020159 | Smith & Nephew Twinfix TI Quick T | 2002 | 24 |
| K100159 | Smith and Nephew Twinfix Ultra TI Suture Anchor | 2010 | 17 |
| K071520 | Renovo Suture Anchors, Models 100-2001 Thru 100-5502X | 2007 | 7 |
| K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to… | 2015 | 6 |
| K982963 | Polymer Threaded Anchor / Suture Combination | 1998 | 4 |
| K083151 | Extremity Medical Suture Anchor | 2009 | 1 |
| K123425 | Twinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SL | 2013 | 0 |
| K983169 | Polymer Threaded Anchor | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 30, 2019 | Class II | Z-1273-2020 | Package design/selection | Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053344 (Smith & Nephew, Inc., 2006) has gone furthest, with 477 descendants of its own.
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?
This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures. The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency. The PeBA Series Anchor/Suture Combination is…
Read the full statement (165 words)
This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.
The Cinch Series Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
The PeBA Series Anchor/Suture Combination is intended for the fixation of surgical suture material 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
Deltoid repairs
Foot and Ankle:
Hallux Valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand:
Scapholunate ligament reconstructions
Ulnar or radial collateral ligament reconstructions
Tennis elbow repair
Biceps tendon reattachment
Knee:
Extra-capsular repairs:
a. medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament
Iliotibial band tenodesis
Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
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/K972326 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972326: Peba Anchor/Suture Combination.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972326
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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