510(k) · Cleared
ClearedOneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B-One Ortho, Corp. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Nov 4, 2021 as substantially equivalent to K192484 (Aju Pharm Co., Ltd., 2020) and 4 other predicates after a 52-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Nov 4, 2021
- Review
- 52 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K911837 (1991). 124 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 9 generations between
- 3 generations backK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- 2 generations backK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014
- 1 generation backK192709 Fixone All Suture AnchorAju Pharm Co., Ltd. · 2020
- This deviceK212912 OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors…B-One Ortho, Corp. · 2021
Show all 13 generations
- Root · 13 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 12 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 11 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 10 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 9 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 8 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 7 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 6 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 5 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 4 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 3 generations backK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- 2 generations backK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014
- 1 generation backK192709 Fixone All Suture AnchorAju Pharm Co., Ltd. · 2020
- This deviceK212912 OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors…B-One Ortho, Corp. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −12 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −11 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −10 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −9 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −8 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −7 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −6 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −5 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| −4 | 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 | — |
| −2 | K133224 | Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2… | Conmed Corporation | 2014 | — |
| −1 | K192709 | Fixone All Suture Anchor | Aju Pharm Co., Ltd. | 2020 | — |
| 0 (this device) | K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All… | B-One Ortho, Corp. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 13 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K192484 | Fixone Biocomposite AnchorSummary page 5…Arthroscope 888.1100 Legally Marketed Fixone Biocomposite Anchors; K192484 Predicate Devices to Fixone Biocomposite Small Anchors; K192032 Which Substantial Fixone All Suture Anchors; K19… | 2020 |
| * | K192032 | Fixone Biocomposite Small AnchorSummary page 5…888.1100 Legally Marketed Fixone Biocomposite Anchors; K192484 Predicate Devices to Fixone Biocomposite Small Anchors; K192032 Which Substantial Fixone All Suture Anchors; K192709 Equivalence is Claimed: Fixone Interfernece Screws; K193497… | 2020 |
| * | K192709 | Fixone All Suture AnchorSummary page 5…Fixone Biocomposite Anchors; K192484 Predicate Devices to Fixone Biocomposite Small Anchors; K192032 Which Substantial Fixone All Suture Anchors; K192709 Equivalence is Claimed: Fixone Interfernece Screws; K193497 JOINIX Cannula System; K162070… | 2020 |
| * | K193497 | Fixone Biocomposite Interference ScrewSummary page 5…Fixone Biocomposite Small Anchors; K192032 Which Substantial Fixone All Suture Anchors; K192709 Equivalence is Claimed: Fixone Interfernece Screws; K193497 JOINIX Cannula System; K162070… | 2021 |
| * | K162070 | Joinix Cannular SystemSummary page 5…bstantial Fixone All Suture Anchors; K192709 Equivalence is Claimed: Fixone Interfernece Screws; K193497 JOINIX Cannula System; K162070 P 1 of 3… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 11 companies; a new generation was cleared every 1.6 years on median.
- 16 of the 124 ancestors have a recall of any class.
- 1 other device also cites its predicate K192484.
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. 2021, this device’s year, is highlighted.
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 OneFix Biocomposite Anchors are intended for fixation ofsuture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral…
Read the full statement (328 words)
The OneFix Biocomposite Anchors are intended for fixation ofsuture (soft tissue) to bone in the shoulder, foot/ankle,
knee and elbow in the following procedures:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair,
Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
The OneFix Biocomposite Small Anchors are intended to be used for suture (soft tissue) fixation to bone in the foot,
ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux
Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral
ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral repair
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The
OneFix All Suture Anchor may be used in either arthroscopic or open surgical procedures. After the suture strands are
anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In
conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems
stabilize the damaged soft tissue.
The OneFix Biocomposite Interference Screws are indicated for fixation of bone-tendon-bone or soft tissue grafts during
Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
The OneFix Cannula System is intended for introduction of instrumentation through a portal for surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212912: OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212912
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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