510(k) · Cleared
ClearedEXPERT - Flexible 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 Nov 1, 2024 as substantially equivalent to K200332 (GM Dos Reis Industria e Comercio Ltda., 2020) and 2 other predicates after an 88-day review. Its family tree reaches back 12 generations to 1979.
- Decided
- Nov 1, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K792022 (1979). 62 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations between
- 3 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 2 generations backK111032 CMC Cable FixInstratek, Inc. · 2011
- 1 generation backK200332 EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2020
- This deviceK242311 EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2024
Show all 12 generations
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 11 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 10 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 9 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 8 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 7 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 6 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 5 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 4 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 3 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 2 generations backK111032 CMC Cable FixInstratek, Inc. · 2011
- 1 generation backK200332 EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2020
- This deviceK242311 EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −11 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −10 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −9 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −8 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −7 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −6 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −5 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −4 | K071978 | Mini Tightrope FT Repair Kit | Arthrex, Inc. | 2007 | — |
| −3 | K090107 | Mini Tightrope | Arthrex, Inc. | 2009 | — |
| −2 | K111032 | CMC Cable Fix | Instratek, Inc. | 2011 | — |
| −1 | K200332 | EXPERT - Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. | 2020 | — |
| 0 (this device) | 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 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K200332 | EXPERT - Joint Fixation SystemSummary page 5…21 CFR 888.3030 III. Predicate Devices: Legally marketed devices to which we are claiming “Substantial Equivalence” are the following: EXPERT - Joint Fixation System (K200332) (Primary predicate device); ACL TightRope (K100652) (Additional predicate device); TightRopeTM Acromioclavicular (AC) Device (K0… | 2020 |
| * | K100652 | Acl TightropeSummary page 5…arketed devices to which we are claiming “Substantial Equivalence” are the following: EXPERT - Joint Fixation System (K200332) (Primary predicate device); ACL TightRope (K100652) (Additional predicate device); TightRopeTM Acromioclavicular (AC) Device (K052776) (Additional predicate device); Suture Anchors… | 2010 |
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 5…g: EXPERT - Joint Fixation System (K200332) (Primary predicate device); ACL TightRope (K100652) (Additional predicate device); TightRopeTM Acromioclavicular (AC) Device (K052776) (Additional predicate device); Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors (K223114) (Reference device). IV.… | 2005 |
| † | K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | 2023 |
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 45 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 62 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. 2024, 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 - Flexible 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 EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following: EXPERT FAST - SYNDESMOSIS and EXPERT…
Read the full statement (172 words)
The EXPERT - Flexible 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 EXPERT
- Flexible Joint Fixation System are intended to provide fixation during the healing process following:
EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL:
Syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber
B and C ankle fractures.
EXPERT ACL and EXPERT ACL II:
Fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for
distributing suture tension over areas of ligament or tendon repair. Specifically, these models are offered for
Anterior Cruciate Ligament (ACL) Repair.
EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC:
Specifically, these models are intended to provide fixation during the healing process following a syndesmotic
trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242311: EXPERT - Flexible 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/K242311
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