510(k) Report

510(k) · Cleared

Cleared

Acetabular Brush #1202 & Femoral Con. Brush #1202

K870329510(k) TraditionalCleared Feb 13, 198716-day reviewClass I21 CFR 878.4800

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

Biodynamic Technologies, Inc. · HTR Rasp

Cleared on Feb 13, 1987 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 13, 1987
Review
16 days
Class
Class I
Product code
HTR
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K870329Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HTR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All HTR devices

HTR Rasp: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTR

FDA has decided no HTR device since 2007.

Median 510(k) review, days · HTR

Too few HTR 510(k)s in any year since 2007 to give a median.

Recalls per year · HTR

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HTR

8in 2025

2007: 32008: 122009: 222010: 82011: 92012: 122013: 122014: 102015: 142016: 392017: 272018: 142019: 132020: 72021: 72022: 152023: 92024: 112025: 8
2007high 39 (2016) · low 3 (2007)2025

MAUDE reports naming product code HTR, 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
20070—03
20080—112
20090—022
20100—08
20110—09
20120—012
20130—012
20140—010
20150—014
20160—039
20170—027
20180—014
20190—013
20200—07
20210—07
20220—015
20230—09
20240—011
20250—08
20260—0—

More from Biodynamic Technologies, Inc.

30 FDA decisions under this applicant name. See the company

  • K990436Ultimax Trochanteric Intramedullary Rod SystemBiodynamic Technologies, Inc. · 1999
  • K990481Ultimax Distal Radial (Volar) Locking Plate SystemBiodynamic Technologies, Inc. · 1999
  • K990513Ultimax Cortical Bone ScrewsBiodynamic Technologies, Inc. · 1999
  • K981230Ultimax Distal Femoral Intramedullary Rod SystemBiodynamic Technologies, Inc. · 1998
  • K980102Bti Humeral Intramedullary Rod SystemBiodynamic Technologies, Inc. · 1998

Recent decisions in HTR

The HTR category page

  • K870333Biodynamics Small Joint Brush #1203Biodynamic Technologies, Inc. · 1987
  • K870349Biodynamics Femoral Canal Brush #1201Biodynamic Technologies, Inc. · 1987
  • K813093Richards Acetabular BrushRichard'S Medical Equip., Inc. · 1981
  • K812506The ArthrofileDyonics, Inc. · 1981
  • K780771Micro RaspsAmsco Co. · 1978

https://510kreport.com/device/K870329 · printed Nov 4, 2026

Cite this page

510(k) Report. “K870329: Acetabular Brush #1202 & Femoral Con. Brush #1202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K870329

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