510(k) · Cleared
ClearedMultifilament Stainless Steel Sutures with Crimps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pontis Orthopaedics, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 26, 2014 as substantially equivalent to K041115 (Depuy Mitek, A Johnson & Johnson Company, 2004) and 4 other predicates after a 217-day review. Its family tree reaches back 9 generations to 1979.
- Decided
- Jun 26, 2014
- Review
- 217 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K792022 (1979). 71 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 1 generation backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- This deviceK133579 Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC · 2014
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 1 generation backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- This deviceK133579 Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −2 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| −1 | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| 0 (this device) | K133579 | Multifilament Stainless Steel Sutures with Crimps | Pontis Orthopaedics, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K041115 | Gii Quickanchor PlusSummary page 1…Threaded Metallic Bone Fixation Fastener Section § CFR 888.3040 Product Code Primary - MBI Predicate Device(s) Mitek GIlI Quick Anchor Plus - K041 115 Arthrex Swivelock - K 101823 Smith and Nephew Endlobulton - K08 1098… | 2004 |
| * | K101823 | Arthrex Swivelock AnchorsSummary page 1…§ CFR 888.3040 Product Code Primary - MBI Predicate Device(s) Mitek GIlI Quick Anchor Plus - K041 115 Arthrex Swivelock - K 101823 Smith and Nephew Endlobulton - K08 1098 PONTiS Orthopaedlics ferroFlBRETM - K08 106… | 2011 |
| * | K081098 | Endobutton Continuous Loop (CL)Summary page 1…Predicate Device(s) Mitek GIlI Quick Anchor Plus - K041 115 Arthrex Swivelock - K 101823 Smith and Nephew Endlobulton - K08 1098 PONTiS Orthopaedlics ferroFlBRETM - K08 1060 Pioneer Surgical Technologies SilCoat… | 2008 |
| * | K081060 | Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5Summary page 1…Arthrex Swivelock - K 101823 Smith and Nephew Endlobulton - K08 1098 PONTiS Orthopaedlics ferroFlBRETM - K08 1060 Pioneer Surgical Technologies SilCoat Sternal Cable - K993286 Device Description Multifilament stainle… | 2008 |
| * | K993286 | Pioneer Silicoat Sternal CableSummary page 1…w Endlobulton - K08 1098 PONTiS Orthopaedlics ferroFlBRETM - K08 1060 Pioneer Surgical Technologies SilCoat Sternal Cable - K993286 Device Description Multifilament stainless steel sutures with crimps are intended for use in Soft tiss… | 1999 |
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 35 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 71 ancestors have a recall of any class.
- 3 other devices also cite its predicate K041115.
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. 2014, 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?
Multifilament stainless steel sutures with crimps are intended for use in soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and wrist for indications such as: Elbow - biceps tendon attachment; Foot and Ankle - achilles tendon attachment; Knee - patella tendon attachment to bone; Shoulder -biceps tendon tenodesis; Wrist -scapho-lunate approximation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133579 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133579: Multifilament Stainless Steel Sutures with Crimps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133579
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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