510(k) Report

510(k) · Cleared

Cleared

Clearview Wrist Fixator

K020311510(k) TraditionalCleared Apr 29, 200290-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rigid FX Orthopedics, Incorporated · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Apr 29, 2002 as substantially equivalent to K992970 (Hand Biomechanics Lab, Inc., 1999) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1997.

Decided
Apr 29, 2002
Review
90 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K970713 (1997). 9 ancestors in all, the oldest K942906 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestorK970713 · Compass Universal Hinge · Smith & Nephew, Inc., Orthopaedic Div. · 1997K980370 · Biosymmetric Proximal Interphalangeal Joint Fixator · Biomet, Inc. · 1998K992970 · Digit Widget · Hand Biomechanics Lab, Inc. · 199919901992199419961998200020022004
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors K992970 · Digit Widget · Hand Biomechanics Lab, Inc. · 1999K980370 · Biosymmetric Proximal Interphalangeal Joint Fixator · Biomet, Inc. · 1998K970713 · Compass Universal Hinge · Smith & Nephew, Inc., Orthopaedic Div. · 19970
  1. Root · 3 generations backK970713 Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div. · 1997
  2. 2 generations backK980370 Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc. · 1998
  3. 1 generation backK992970 Digit WidgetHand Biomechanics Lab, Inc. · 1999
  4. This deviceK020311 Clearview Wrist FixatorRigid FX Orthopedics, Incorporated · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K970713Compass Universal HingeSmith & Nephew, Inc., Orthopaedic Div.1997—
−2K980370Biosymmetric Proximal Interphalangeal Joint FixatorBiomet, Inc.1998—
−1K992970Digit WidgetHand Biomechanics Lab, Inc.1999—
0 (this device)K020311Clearview Wrist FixatorRigid FX Orthopedics, Incorporated2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610
199810
199920
FIG. 1 — Lineage of K020311, 1997–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K992970Digit Widget
Summary page 1
…ures to Predicate Device(s): This device is similar in pin placement, materials, function, and indications to the Agee Wristfack marketed by Hand Biomechanics Lab, Inc. (K992970), Synthes Articulating Distal Radius Fixator (K984498) and the DFS Wrist Fixator marketed by EBI/Orthofix (K993649). === Page 2…
Hand Biomechanics Lab, Inc.1999—
*K984498Synthes (Usa) Articulating Distal Radius (Adrf) System
Summary page 1
…pin placement, materials, function, and indications to the Agee Wristfack marketed by Hand Biomechanics Lab, Inc. (K992970), Synthes Articulating Distal Radius Fixator (K984498) and the DFS Wrist Fixator marketed by EBI/Orthofix (K993649). p v'“mc.'"o Public Health Service ot BrAlny {é…
Synthes (Usa)1999—
*K993649Ebi Xfix DFS Wristfix System
Summary page 1
…ee Wristfack marketed by Hand Biomechanics Lab, Inc. (K992970), Synthes Articulating Distal Radius Fixator (K984498) and the DFS Wrist Fixator marketed by EBI/Orthofix (K993649). p v'“mc.'"o Public Health Service ot BrAlny {é DEPARTMENT OF HEALTH & HUMAN SERVICES - - . B ' | S 3 Food and…
Ebi, L.P.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 5 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • None of the 9 ancestors has a recall.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The ClearView™ Wrist Fixator is indicated for single use for fixation of distal fractures in upper extremity applications. This device provides alignment, reduction, and stabilization of fractures, corrective osteotomies, and soft tissue deformities. Common fractures indicated for this use:

fractures of the wrist with ligamentous instability

comminuted intra-articular radius fractures

post-traumatic reconstruction for joint stiffness

Colles Fracture

distal radius fractures (Types B and C)

Frykman Type 1L, I'V, VII and VIII radius fractures

any wrist fracture requiring distraction

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Rigid FX Orthopedics, Incorporated

2 FDA decisions under this applicant name. See the company

  • K022423External Fixation RingRigid FX Orthopedics, Incorporated · 2002

Recent decisions in KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K020311 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020311: Clearview Wrist Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020311

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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