510(k) · Cleared
Recalled · Class III · 2016BI-Cortical Bio-Post and Washer, Model AR-1367B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HTN Washer, Bolt Nut
Cleared on Feb 18, 2005 as substantially equivalent to K023119 (Arthrex, Inc., 2002) and 4 other predicates after a 95-day review. Its family tree reaches back 5 generations to 1979. It has been recalled once.
- Decided
- Feb 18, 2005
- Review
- 95 days
- Class
- Class II
- Product code
- HTN
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 5 generations to K792022 (1979). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 4 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 3 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 2 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 1 generation backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- This deviceK043145 BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −4 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −3 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −2 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −1 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| 0 (this device) | K043145 | BI-Cortical Bio-Post and Washer, Model AR-1367B | Arthrex, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 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 HTN? 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.4 · 6 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 |
|---|---|---|---|
| * | K023119 | BI-Cortical Bio Post and Washer, Model AR-1367BSummary page 1…Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener PREDICATE DEVICES: K023119, Bi-Cortical Bio-Post MT and Washers K01 1495, Bio-Post M T and… | 2002 |
| * | K011495 | Arthrex Bio-Post and WasherSummary page 1…Smooth or threaded metallic bone fixation fastener PREDICATE DEVICES: K023119, Bi-Cortical Bio-Post MT and Washers K01 1495, Bio-Post M T and Washers K021932, 6.5 mm Cannulated Screw… | 2001 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 1…ATE DEVICES: K023119, Bi-Cortical Bio-Post MT and Washers K01 1495, Bio-Post M T and Washers K021932, 6.5 mm Cannulated Screw K012001, SmartScrew M T K030900, OTPS TM Biodegradab… | 2002 |
| * | K012001 | SmartscrewSummary page 1…Bio-Post MT and Washers K01 1495, Bio-Post M T and Washers K021932, 6.5 mm Cannulated Screw K012001, SmartScrew M T K030900, OTPS TM Biodegradable Fixation System DEVICE DESCRIPTION… | 2001 |
| * | K030900 | Inion Otps Biodegradable Fixaton SystemSummary page 1…T and Washers K021932, 6.5 mm Cannulated Screw K012001, SmartScrew M T K030900, OTPS TM Biodegradable Fixation System DEVICE DESCRIPTION AND INTENDED USE: The Arthrex Bi-Cortical Bio-PostTM and Washers devic… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2016 | Class III | Z-2918-2016 | Packaging process control | The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 15 ancestors have a recall of any class.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 1 | — | 0 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
1) The Arthrex Bi-Cortical Bio-PostTM and Washers device is intended as an anchor device for suture or to secure soft tissue directly to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial…
Read the full statement (171 words)
1) The Arthrex Bi-Cortical Bio-PostTM and Washers device is intended as an anchor device for suture or to secure soft tissue directly to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repairs, 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, Reconstruction, Midfoot Reconstruction.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.
Hand/Wrist: Scaphaolunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, UlInar or Radial Collateral Ligament Reconstruction.
2) The Arthrex Bi-Cortical Bio-Post MT and Washers device is intended for the maintenance of alignment, reduction, and fixation of fractures, osteotomies or arthrodesis of the upper extremity, ankle and foot.
Fusions/fracture of Phalangeal, Metacarpal, and Carpal
Wrist arthrodesis
Fractures of Distal radius, Olecranon, Radial head, Humeral condylar, Cancellous
Osteotomies Malleolus, Ankle fractures, Metatarsal
Correction of hallux valgus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043145: BI-Cortical Bio-Post and Washer, Model AR-1367B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043145
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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