510(k) Report

510(k) · Cleared

Cleared

Buechel-Pappas Humeral Head Resurfacing Component

K992394510(k) TraditionalCleared Oct 15, 199988-day reviewClass II21 CFR 888.3690

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

Endotec, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Oct 15, 1999 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided
Oct 15, 1999
Review
88 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
0

12 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2003: 1 descendant cleared2016: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2019: 2 descendants cleared2018: 3 descendants cleared2022: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK992394 Buechel-Pappas Humeral Head Resurfacing ComponentEndotec, Inc. · 1999
  2. Descendant · cites it directly · 10 of its ownK023096 Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK131298 Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013
  4. Descendant · 2 generations on · 7 of its ownK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
  5. Descendant · 3 generations on · 3 of its ownK181287 Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018
  6. Descendant · 3 generations on · 2 of its ownK182500 Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2003: 12013: 12014: 12016: 12018: 32019: 22020: 12022: 12025: 1
2003high 3 (2018) · low 0 (2004)2026

Most influential descendants

Showing 5 of 12 · See all
  • K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc. · 2003 · cites it directly10descendants
  • K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013 · 2 generations on8descendants
  • K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016 · 2 generations on7descendants
  • K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018 · 3 generations on3descendants
  • K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc. · 2019 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992394Buechel-Pappas Humeral Head Resurfacing ComponentEndotec, Inc.1999—
+1K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc.20035
+2K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.2013—
+2K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC2016—
+3K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.2018—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201310
201410
201610
201830
201920
202010
202210
202510
FIG. 1 — Lineage of K992394, 1999–2025Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HSD? 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 HSD device

  1. #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K023096Contoured Articular Prosthesis (Cap) Humeral Head Resurfacing SystemStd Mfg., Inc.200310
K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC20200

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, K023096 (Std Mfg., Inc., 2003) has gone furthest, with 10 descendants of its own.

How does its category compare?

All HSD devices

HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSD

1in 2024

2007: 42008: 32011: 22012: 22013: 42014: 12016: 32018: 12020: 22022: 12024: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007: 72 days median2008: 92 days median2013: 218 days median2016: 145 days median
2007high 218 (2013) · low 72 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HSD

1in 2020

2008: 22009: 22017: 32018: 12020: 1
2007high 3 (2017) · low 0 (2007)2026

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

Adverse event reports per year · HSD

757in 2025

2007: 1282008: 2592009: 1562010: 2252011: 2412012: 2542013: 2882014: 4342015: 5742016: 7842017: 9852018: 6492019: 8302020: 6582021: 5732022: 5082023: 5862024: 6932025: 757
2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, 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
20074720128
20083922259
20090—2156
20100—0225
20112—0241
20122—0254
201342180288
20141—0434
20150—0574
201631450784
20170—3985
20181—1649
20190—0830
20202—1658
20210—0573
20221—0508
20230—0586
20241—0693
20250—0757
20260—0—

What is it indicated for?

The BUECHEL-PAPPAS™ Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Biocoat® porous coated components are intended for cemented use only.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Endotec, Inc.

15 FDA decisions under this applicant name. See the company

  • K081400Fanning-Pappas Modular Knee BearingEndotec, Inc. · 2009
  • K012702Buechel-Pappas (B-P) Fixed Bearing New Jersey (NJ) Total Knee, Model 1Endotec, Inc. · 20021 recall
  • K982418Buechel-Pappas Modular Salvage StemEndotec, Inc. · 1999
  • K963101B-P Hemispherical Acetabular ComponentEndotec, Inc. · 19971 recall
  • K963100Tronzo Acetabular Fixation Component (1 99-02-00XX (Ace. Fixation Cup) XX=OD of Ace. CupEndotec, Inc. · 1997

Recent decisions in HSD

The HSD category page

  • K233260Univers Revers CA Head and AdapterArthrex, Inc. · 2024
  • K221232Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
  • K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

https://510kreport.com/device/K992394 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992394: Buechel-Pappas Humeral Head Resurfacing Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992394

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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