510(k) Report

510(k) · Cleared

Recalled · 2009

Normed Titanium Osteotomy Plating System

K022325510(k) TraditionalCleared Sep 9, 200254-day reviewClass II21 CFR 888.3030Recalls 1

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

Osteomedics, Inc. · HRS Plate, Fixation, Bone

Cleared on Sep 9, 2002 after a 54-day review. The FDA summary names no predicate by number. 521 later devices descend from it. It has been recalled once.

Decided
Sep 9, 2002
Review
54 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
0

521 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2006: 1 descendant cleared2015: 42 descendants cleared2014: 26 descendants cleared2012: 19 descendants cleared2005: 3 descendants cleared2013: 18 descendants cleared2016: 18 descendants cleared2022: 35 descendants cleared2010: 8 descendants cleared2017: 46 descendants cleared2009: 2 descendants cleared2020: 38 descendants cleared2011: 7 descendants cleared2008: 2 descendants cleared2007: 2 descendants cleared2024: 49 descendants cleared2023: 37 descendants cleared2018: 21 descendants cleared2019: 26 descendants cleared2021: 31 descendants cleared2026: 50 descendants cleared2025: 39 descendants cleared200020052010201520202025
  1. This deviceK022325 Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 2002
  2. Descendant · cites it directly · 410 of its ownK061808 Darco Locking Bone Plate SystemDarco International, Inc. · 2006 · Recalled
  3. Descendant · 2 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
  4. Descendant · 3 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  5. Descendant · 2 generations on · 256 of its ownK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
  6. Descendant · cites it directly · 249 of its ownK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004

Showing 5 of 521 descendants. See all descendants

Descendants cleared per year

2004: 12005: 32006: 12007: 22008: 22009: 22010: 82011: 72012: 192013: 182014: 262015: 422016: 182017: 462018: 212019: 262020: 382021: 312022: 352023: 372024: 492025: 392026: 50
2004high 50 (2026) · low 1 (2004)2026

Most influential descendants

Showing 5 of 521 · See all
  • K061808Darco Locking Bone Plate SystemDarco International, Inc. · 2006 · cites it directly410descendants
  • K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 2 generations on342descendants
  • K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 3 generations on339descendants
  • K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008 · 2 generations on256descendants
  • K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004 · cites it directly249descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022325Normed Titanium Osteotomy Plating SystemOsteomedics, Inc.2002—
+1K061808Darco Locking Bone Plate SystemDarco International, Inc.20063
+2K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081
+3K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
+2K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008—
+1K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200530
200610
200720
200820
200920
201080
201170
2012190
2013180
2014260
2015420
2016180
2017460
2018210
2019260
2020380
2021310
2022350
2023370
2024490
2025390
2026500
FIG. 1 — Lineage of K022325, 2002–2026Source: 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 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?

The FDA summary names no predicate by number.

What descends from it? (521)

See all 521

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

NumberDeviceApplicantDecidedDescendants
K061808Darco Locking Bone Plate SystemDarco International, Inc.2006410
K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004249
K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited201258
K140397Paralock Plating System / Tuffnek ScrewParagon 28201431
K151407RECON systemNormed Medizin-Technik GmbH20154

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 14, 2009Not classifiedZ-1524-2009PendingScrewdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K061808 (Darco International, Inc., 2006) has gone furthest, with 410 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.

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?

The Normed Titanium Osteotomy Plating System intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes skeleton. The system can be used in both adult and pediatric patients.

Indications for use as stated in the FDA summary.

More from Osteomedics, Inc.

9 FDA decisions under this applicant name. See the company

  • K022035Osteomedics Resorbable Small Fixation System, OsteosorbOsteomedics, Inc. · 2003
  • K022324Normed Titanium Calcaneus Plating with Locking Screw SystemOsteomedics, Inc. · 20021 recall
  • K022231Normed Distal Radius Reconstruction SystemOsteomedics, Inc. · 2002
  • K022230Normed Mini External Fixator SystemOsteomedics, Inc. · 2002
  • K022323Normed Titanium Rondo Fix Fusion Plates and Screw SystemOsteomedics, Inc. · 2002

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/K022325 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022325: Normed Titanium Osteotomy Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022325

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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