510(k) Report

510(k) · Cleared

Recalled · 2009

Normed Titanium Calcaneus Plating with Locking Screw System

K022324510(k) TraditionalCleared Sep 17, 200262-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 17, 2002 after a 62-day review. The FDA summary names no predicate by number. 86 later devices descend from it. It has been recalled once.

Decided
Sep 17, 2002
Review
62 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
0

86 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2014: 3 descendants cleared2016: 1 descendant cleared2012: 1 descendant cleared2024: 9 descendants cleared2015: 6 descendants cleared2017: 10 descendants cleared2021: 8 descendants cleared2023: 12 descendants cleared2018: 2 descendants cleared2022: 4 descendants cleared2026: 9 descendants cleared2020: 8 descendants cleared2019: 5 descendants cleared2025: 6 descendants cleared200020052010201520202025
  1. This deviceK022324 Normed Titanium Calcaneus Plating with Locking Screw SystemOsteomedics, Inc. · 2002
  2. Descendant · cites it directly · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
  3. Descendant · cites it directly · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  4. Descendant · 2 generations on · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
  5. Descendant · 2 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
  6. Descendant · 2 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22014: 32015: 62016: 12017: 102018: 22019: 52020: 82021: 82022: 42023: 122024: 92025: 62026: 9
2012high 12 (2023) · low 1 (2012)2026

Most influential descendants

Showing 5 of 86 · See all
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly58descendants
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · cites it directly31descendants
  • K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · 2 generations on28descendants
  • K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 2 generations on24descendants
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 2 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022324Normed Titanium Calcaneus Plating with Locking Screw SystemOsteomedics, Inc.2002—
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited20121
+1K140397Paralock Plating System / Tuffnek ScrewParagon 282014—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited20142
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH20132
+2K162674BioPro Foot Plating SystemsBiopro, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201430
201560
201610
2017100
201820
201950
202080
202180
202240
2023120
202490
202560
202690
FIG. 1 — Lineage of K022324, 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? (86)

See all 86

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

NumberDeviceApplicantDecidedDescendants
K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited201258
K140397Paralock Plating System / Tuffnek ScrewParagon 28201431
K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH20132
K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160

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, K111678 (Ortho Solutions Limited, 2012) has gone furthest, with 58 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?

Normed Titanium Calcaneus Plating with Locking Screw System intended for use in Intra and extra -artcular fiactures, joint depression, non-displaced and tonque type, multifiagmentary fractures, stabilization and fixation of fiesh f?actures, revision procedures, joint fiision, and reconstruction of calcaneus bones. 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
  • K022231Normed Distal Radius Reconstruction SystemOsteomedics, Inc. · 2002
  • K022230Normed Mini External Fixator SystemOsteomedics, Inc. · 2002
  • K022325Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 20021 recall
  • 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/K022324 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022324: Normed Titanium Calcaneus Plating with Locking Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022324

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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