510(k) · Cleared
ClearedPUMA System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panther Orthopedics, Inc. · HTN Washer, Bolt Nut
Cleared on Mar 1, 2018 as substantially equivalent to K090107 (Arthrex, Inc., 2009) and 2 other predicates after a 266-day review. Its family tree reaches back 10 generations to 1979.
- Decided
- Mar 1, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K792022 (1979). 62 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations between
- 3 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 2 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 1 generation backK090107 Mini TightropeArthrex, Inc. · 2009
- This deviceK171703 PUMA SystemPanther Orthopedics, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 8 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 7 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 6 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 5 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 4 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 3 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 2 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 1 generation backK090107 Mini TightropeArthrex, Inc. · 2009
- This deviceK171703 PUMA SystemPanther Orthopedics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −9 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −8 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −7 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −6 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −5 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −3 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −2 | K071978 | Mini Tightrope FT Repair Kit | Arthrex, Inc. | 2007 | — |
| −1 | K090107 | Mini Tightrope | Arthrex, Inc. | 2009 | — |
| 0 (this device) | K171703 | PUMA System | Panther Orthopedics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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? (3)
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 |
|---|---|---|---|
| * | K090107 | Mini TightropeSummary page 5…The PUMA System is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K090107 Mini TightRope / Arthrex, Inc. K043248 TightRope Syndesmosis Device /… | 2009 |
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 5…Predicate Device Name / Manufacturer Primary Predicate K090107 Mini TightRope / Arthrex, Inc. K043248 TightRope Syndesmosis Device / Arthrex, Inc. K142727 CrossCLIP Implant System / OrthoDiscovery Group, LLC SUMM… | 2005 |
| * | K142727 | CrossCLIP Implant SystemSummary page 5…Primary Predicate K090107 Mini TightRope / Arthrex, Inc. K043248 TightRope Syndesmosis Device / Arthrex, Inc. K142727 CrossCLIP Implant System / OrthoDiscovery Group, LLC SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have… | 2014 |
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 39 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 62 ancestors have a recall of any class.
- 6 other devices also cite its predicate K090107.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
The PUMA System is intended as an adjunct in fracture repair involving metaphyseal, and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The PUMA System when used for fixation of bone-to-bone or soft tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over…
Read the full statement (151 words)
The PUMA System is intended as an adjunct in fracture repair involving metaphyseal, and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The PUMA System when used for fixation of bone-to-bone or soft tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, the PUMA System is indicated to provide fixation during the healing process for the following:
• Fixation of Syndesmosis disruptions in connection with Weber B and C ankle fractures.
• Fixation of Syndesmosis disruptions in connection with dorsal distal radioulnar ligament (DRUL) disruptions.
• Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc Injury.
• Hallux Valgus reconstruction by providing for the reduction of 1st and 2nd metatarsal intermetatarsal angle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171703: PUMA System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171703
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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