510(k) Report

510(k) · Cleared

Cleared

Acromed Bone Plate Bender

K872949510(k) TraditionalCleared Oct 15, 198779-day reviewClass I21 CFR 888.4540

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

Buckman Co., Inc. · HXW Bender

Cleared on Oct 15, 1987 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 15, 1987
Review
79 days
Class
Class I
Product code
HXW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K872949Source: 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 HXW? 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 HXW devices

HXW Bender: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HXW

FDA has decided no HXW device since 2007.

Median 510(k) review, days · HXW

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

Recalls per year · HXW

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

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

Adverse event reports per year · HXW

30in 2025

2009: 22010: 22011: 12012: 12013: 282014: 42015: 112016: 302017: 222018: 432019: 242020: 162021: 112022: 102023: 122024: 252025: 30
2007high 43 (2018) · low 0 (2007)2025

MAUDE reports naming product code HXW, 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—00
20080—00
20090—02
20100—02
20110—01
20120—01
20130—028
20140—14
20150—011
20160—030
20170—022
20180—043
20190—024
20200—016
20210—011
20220—010
20230—012
20240—025
20250—030
20260—0—

More from Buckman Co., Inc.

111 FDA decisions under this applicant name. See the company

  • K961320Cross Medical Bone Plate System/ CM Bone Plate System/Cross TI Bone Plate SystemBuckman Co., Inc. · 1998
  • K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998
  • K964252OrthochuckBuckman Co., Inc. · 1997
  • K950099Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
  • K960451Webb-Morley Spine SystemBuckman Co., Inc. · 1996

Recent decisions in HXW

The HXW category page

  • K870668Driver-Bender-Extractor, Bone PinMilitary Engineering, Inc. · 1987
  • K870084RD 140 Surgical BenderTerray Manufacturing, Inc. · 1987

https://510kreport.com/device/K872949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K872949: Acromed Bone Plate Bender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872949

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