510(k) Report

510(k) · Cleared

Cleared

TMP Microplating System

K921458510(k) TraditionalCleared Jul 17, 1992112-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

Techmedica, Inc. · HRS Plate, Fixation, Bone

Cleared on Jul 17, 1992 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 104 later devices descend from it.

Decided
Jul 17, 1992
Review
112 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 2 descendants cleared2014: 8 descendants cleared2015: 9 descendants cleared2018: 1 descendant cleared2016: 3 descendants cleared2020: 2 descendants cleared2002: 3 descendants cleared1999: 2 descendants cleared2004: 1 descendant cleared2007: 2 descendants cleared2008: 2 descendants cleared2005: 1 descendant cleared2006: 2 descendants cleared2025: 16 descendants cleared2026: 13 descendants cleared2011: 2 descendants cleared2024: 13 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2022: 4 descendants cleared2010: 1 descendant cleared2023: 10 descendants cleared2021: 3 descendants cleared1990200020102020
  1. This deviceK921458 TMP Microplating SystemTechmedica, Inc. · 1992
  2. Descendant · cites it directly · 87 of its ownK972919 Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded…Bionx Implants, Inc. · 1998
  3. Descendant · 2 generations on · 86 of its ownK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
  4. Descendant · 3 generations on · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
  5. Descendant · 3 generations on · 73 of its ownK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
  6. Descendant · 4 generations on · 65 of its ownK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006

Showing 5 of 104 descendants. See all descendants

Descendants cleared per year

1998: 21999: 22002: 32004: 12005: 12006: 22007: 22008: 22010: 12011: 22012: 22013: 22014: 82015: 92016: 32018: 12020: 22021: 32022: 42023: 102024: 132025: 162026: 13
1998high 16 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 104 · See all
  • K972919Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift ScrewBionx Implants, Inc. · 1998 · cites it directly87descendants
  • K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998 · 2 generations on86descendants
  • K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · 3 generations on79descendants
  • K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · 3 generations on73descendants
  • K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006 · 4 generations on65descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K921458TMP Microplating SystemTechmedica, Inc.1992—
+1K972919Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift ScrewBionx Implants, Inc.1998—
+2K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.1998—
+3K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments1999—
+3K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.2002—
+4K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200230
200410
200510
200620
200720
200820
201010
201120
201220
201320
201480
201590
201630
201810
202020
202130
202240
2023100
2024130
2025160
2026130
FIG. 1 — Lineage of K921458, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (104)

See all 104

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

NumberDeviceApplicantDecidedDescendants
K972919Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift ScrewBionx Implants, Inc.199887
K140508Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc.201414
K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Zimmer, Inc.201412
K141517Zimmer Plates and Screws (ZPS)-Non-Sterile PlatesZimmer, Inc.20140

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, K972919 (Bionx Implants, Inc., 1998) has gone furthest, with 87 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—

More from Techmedica, Inc.

31 FDA decisions under this applicant name. See the company

  • K933935CKS Porous Coated Femoral ComponentTechmedica, Inc. · 1994
  • K932017Techmedica Continuum Hip with HA CoatingTechmedica, Inc. · 1994
  • K931929Techmedica Continuum Hip SystemTechmedica, Inc. · 1994
  • K926387Techmedica Standard Cemented Hip SystemTechmedica, Inc. · 1994
  • K925420Techmedica Standard Bipolar SystemTechmedica, Inc. · 1993

Recent decisions in HRS

The HRS category page

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  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
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  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K921458 · printed Nov 6, 2026

Cite this page

510(k) Report. “K921458: TMP Microplating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921458

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026