510(k) · Cleared
ClearedEXPERT - Joint Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GM Dos Reis Industria e Comercio Ltda. · HTN Washer, Bolt Nut
Cleared on Oct 29, 2020 as substantially equivalent to K090107 (Arthrex, Inc., 2009) and 3 other predicates after a 262-day review. Its family tree reaches back 11 generations to 1979. 1 later device descends from it.
- Decided
- Oct 29, 2020
- Review
- 262 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K792022 (1979). 59 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations between
- 3 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 2 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 1 generation backK111032 CMC Cable FixInstratek, Inc. · 2011
- This deviceK200332 EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2020
- Descendant · cites it directly · 0 of its ownK242311 EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2024
Show all 11 generations
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 9 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 8 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 7 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 6 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 5 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 4 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 3 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 2 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 1 generation backK111032 CMC Cable FixInstratek, Inc. · 2011
- This deviceK200332 EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2020
Most influential descendants
Showing 1 of 1 · See all- K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −10 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −9 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −8 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −7 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −6 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −5 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −4 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −3 | K071978 | Mini Tightrope FT Repair Kit | Arthrex, Inc. | 2007 | — |
| −2 | K090107 | Mini Tightrope | Arthrex, Inc. | 2009 | — |
| −1 | K111032 | CMC Cable Fix | Instratek, Inc. | 2011 | — |
| 0 (this device) | K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020 | — |
| +1 | K242311 | EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (4)
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 4…Classification Regulation 21 CFR 888.3030, Class II Review Panel Orthopedic PREDICATE DEVICE INFORMATION Predicate Devices K090107 - Mini TightRope - Arthrex, Inc. K061925- Mini TightRopeTM Repair Kit - Arthrex, Inc.… | 2009 |
| * | K061925 | Mini Tightrope Repair Kit, Model AR-8911DSSummary page 4…w Panel Orthopedic PREDICATE DEVICE INFORMATION Predicate Devices K090107 - Mini TightRope - Arthrex, Inc. K061925- Mini TightRopeTM Repair Kit - Arthrex, Inc. K043248 - Arthrex TightRopeTM Syndesmosis Devices, Arthr… | 2006 |
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 4…e Devices K090107 - Mini TightRope - Arthrex, Inc. K061925- Mini TightRopeTM Repair Kit - Arthrex, Inc. K043248 - Arthrex TightRopeTM Syndesmosis Devices, Arthrex, Inc. K111032 - CMC Cable FIX - Instratek, Inc. Re… | 2005 |
| * | K111032 | CMC Cable FixSummary page 4…925- Mini TightRopeTM Repair Kit - Arthrex, Inc. K043248 - Arthrex TightRopeTM Syndesmosis Devices, Arthrex, Inc. K111032 - CMC Cable FIX - Instratek, Inc. Reference Devices K100006 – Polyester Non-absorbable Surgical Suture, Polyblend Non-… | 2011 |
| † | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon… | 2010 |
| † | K180626 | Pedimax II - Pedicular Screw Spinal System | 2019 |
| † | K182718 | Mini and Micro Fragments Reconstruction System – GMReis | 2019 |
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 |
|---|---|---|---|
| K242311 | EXPERT - Flexible Joint Fixation System | 2024 | 0 |
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 41 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 59 ancestors have a recall of any class.
- Of its descendants, K242311 (GM Dos Reis Industria e Comercio Ltda., 2024) has gone furthest, with 0 descendants of its own.
- 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. 2020, 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 EXPERT - Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following: Mini EXPERT When used for fixation…
Read the full statement (198 words)
The EXPERT - Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting.
The Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following:
Mini EXPERT
When used for fixation of bone-to-bone, the Mini EXPERT is intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair, such as:
- Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
- Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
- Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
EXPERT Knotless and EXPERT Knotless Dual
Syndesmotic trauma, such as fixation ofsyndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200332: EXPERT - Joint Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200332
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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