510(k) Report

510(k) · Cleared

Cleared

Oic Distal Radius Plating System, Oic Proximal Humerus Plating System, Oic Clavicle Plating System, the Oic Small Fragme

K123832510(k) TraditionalCleared Mar 20, 201397-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

The Orthopaedic Implant Company (Oic) · HRS Plate, Fixation, Bone

Cleared on Mar 20, 2013 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Mar 20, 2013
Review
97 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant cleared2010201520202025
  1. This deviceK123832 Oic Distal Radius Plating System, Oic Proximal Humerus Plating…The Orthopaedic Implant Company (Oic) · 2013
  2. Descendant · cites it directly · 2 of its ownK202971 DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2021
  3. Descendant · cites it directly · 2 of its ownK140357 Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 2014
  4. Descendant · 2 generations on · 1 of its ownK223118 OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 2023
  5. Descendant · 3 generations on · 0 of its ownK242995 OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company · 2024
  6. Descendant · 2 generations on · 0 of its ownK233531 OIC FLEX-FIX™ SystemOrthopaedic Implant Company · 2024

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 12021: 12022: 12023: 12024: 2
2014high 2 (2024) · low 0 (2015)2026

Most influential descendants

Showing 5 of 6 · See all
  • K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2021 · cites it directly2descendants
  • K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 2014 · cites it directly2descendants
  • K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 2023 · 2 generations on1descendant
  • K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company · 2024 · 3 generations on0descendants
  • K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K123832Oic Distal Radius Plating System, Oic Proximal Humerus Plating System, Oic…The Orthopaedic Implant Company (Oic)2013—
+1K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company2021—
+1K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company2014—
+2K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company2023—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company2024—
+2K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
202110
202210
202310
202420
FIG. 1 — Lineage of K123832, 2013–2024Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212
K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142

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?

  • Of its descendants, K202971 (Orthopaedic Implant Company, 2021) has gone furthest, with 2 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

a. Distal Radius Plates are indicated for the fixation of Intra- and extra-articular fractures and osteotomies of the distal radius.

b. Clavicle Plates are indicated for the fixation of fractures, mal-unions, non-unions and osteotomies of the clavicle.

c. Proximal Humerus plates are Indicated for the fixcation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus, particularly in the osteopenic bone.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K123832 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123832: Oic Distal Radius Plating System, Oic Proximal Humerus Plating System, Oic Clavicle Plating System, the Oic Small Fragme.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123832

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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