510(k) · Cleared
Recalled · Class II · 2020All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 18, 2013 as substantially equivalent to K110145 (Biomet, Inc., 2011) after a 248-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Mar 18, 2013
- Review
- 248 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904436 (1990). 15 ancestors in all, the oldest K813581 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 4 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 3 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 2 generations backK071704 Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007
- 1 generation backK110145 Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc. · 2011 · Recalled
- This deviceK122059 All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill…Smith & Nephew, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK163034 SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −4 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −3 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −2 | K071704 | Sleeve and Button Soft Tissue Devices | Biomet Sports Medicine, Inc. | 2007 | — |
| −1 | K110145 | Biomet Sports Medicine Juggerknot Soft Anchor | Biomet, Inc. | 2011 | 3 |
| 0 (this device) | K122059 | All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for… | Smith & Nephew, Inc. | 2013 | — |
| +1 | K163034 | SUTUREFIX Curved Suture Anchor | Smith and Nephew, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K102018 | FDA’s K102018 is Norian Reinforced, Norian Reinforced Fast Set Putty Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K110145 | Biomet Sports Medicine Juggerknot Soft AnchorSummary page 1…APTOR 2.3 PK Suture Anchor M(21018 June 22, 2012 Blomet, Inc. JuggerKnor Soft Anchors K110145 March 4, 2011 Endloscopy T 978-749-1000 Smith & Nephew, Inc.… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163034 | SUTUREFIX Curved Suture Anchor | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2020 | Class II | Z-2746-2020 | Process control | A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill. |
| Jun 2, 2014 | Class II | Z-2049-2014 | Package design/selection | Sterility of device is compromised due to breach in sterile barrier |
| Jun 2, 2014 | Class II | Z-2047-2014 | Package design/selection | Sterility of device is compromised due to breach in sterile barrier |
| Jun 2, 2014 | Class II | Z-2046-2014 | Package design/selection | Sterility of device is compromised due to breach in sterile barrier |
| Jun 2, 2014 | Class II | Z-2048-2014 | Package design/selection | Sterility of device is compromised due to breach in sterile barrier |
| Jun 2, 2014 | Class II | Z-2045-2014 | Package design/selection | Sterility of device is compromised due to breach in sterile barrier |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K163034 (Smith and Nephew, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K110145.
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. 2013, this device’s year, is highlighted.
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?
The Smith &Nephew SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications: Hip Hip capsule repair (Acetabular labrum repair/reconstruction) Shoulder Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis Foot…
Read the full statement (116 words)
The Smith &Nephew SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum repair/reconstruction)
Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy
Elbow, Wrist and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), iliotibial band tenodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122059: All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122059
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