510(k) Report

510(k) · Cleared

Cleared

Precision Harvest & Inlay Instrument Set

K851339510(k) TraditionalCleared Jul 2, 198590-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

Concept, Inc. · HWK Trephine

Cleared on Jul 2, 1985 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 2, 1985
Review
90 days
Class
Class I
Product code
HWK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K851339Source: 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 HWK? 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 HWK devices

HWK Trephine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWK

FDA has decided no HWK device since 2007.

Median 510(k) review, days · HWK

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

Recalls per year · HWK

No recall names HWK since 2007.

Adverse event reports per year · HWK

5in 2025

2008: 62010: 52012: 12013: 132014: 52015: 52016: 62017: 72018: 142019: 122020: 132021: 102022: 52023: 92024: 82025: 5
2007high 14 (2018) · low 0 (2007)2025

MAUDE reports naming product code HWK, 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—06
20090—00
20100—05
20110—00
20120—01
20130—013
20140—05
20150—05
20160—06
20170—07
20180—014
20190—012
20200—013
20210—010
20220—05
20230—09
20240—08
20250—05
20260—0—

More from Concept, Inc.

84 FDA decisions under this applicant name. See the company

  • K912640Concept Endosteal Fixation DeviceConcept, Inc. · 1992
  • K912957Concept MicromillConcept, Inc. · 1991
  • K896648Concept Unicompartmental Knee SystemConcept, Inc. · 1990
  • K894929Staple Fixation SystemConcept, Inc. · 1989
  • K892376Intravision (TM) Arthroscope System (Add'l Appli.)Concept, Inc. · 1989

https://510kreport.com/device/K851339 · printed Nov 6, 2026

Cite this page

510(k) Report. “K851339: Precision Harvest & Inlay Instrument Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851339

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