510(k) Report

510(k) · Cleared

Cleared

Select Shoulder System

K873679510(k) TraditionalCleared Nov 17, 198764-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

Intermedics Orthopedics · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Nov 17, 1987 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 259 later devices descend from it.

Decided
Nov 17, 1987
Review
64 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
0

259 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2006: 5 descendants cleared2008: 3 descendants cleared2012: 7 descendants cleared2010: 5 descendants cleared2013: 8 descendants cleared2014: 11 descendants cleared2011: 10 descendants cleared2007: 2 descendants cleared2017: 14 descendants cleared2020: 18 descendants cleared2016: 12 descendants cleared2019: 20 descendants cleared2015: 6 descendants cleared2026: 22 descendants cleared2021: 22 descendants cleared2022: 22 descendants cleared2018: 17 descendants cleared2024: 16 descendants cleared2025: 21 descendants cleared2023: 17 descendants cleared1990200020102020
  1. This deviceK873679 Select Shoulder SystemIntermedics Orthopedics · 1987
  2. Descendant · cites it directly · 258 of its ownK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
  3. Descendant · 2 generations on · 257 of its ownK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
  4. Descendant · 3 generations on · 199 of its ownK061439 Aequalis Reversed ProsthesisTornier · 2006
  5. Descendant · 3 generations on · 179 of its ownK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
  6. Descendant · 4 generations on · 178 of its ownK071948 Aequalis Reversed AdapterTornier · 2007

Showing 5 of 259 descendants. See all descendants

Descendants cleared per year

2004: 12006: 52007: 22008: 32010: 52011: 102012: 72013: 82014: 112015: 62016: 122017: 142018: 172019: 202020: 182021: 222022: 222023: 172024: 162025: 212026: 22
2004high 22 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 259 · See all
  • K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier · 2004 · cites it directly258descendants
  • K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006 · 2 generations on257descendants
  • K061439Aequalis Reversed ProsthesisTornier · 2006 · 3 generations on199descendants
  • K081059Aequalis Reversed Shoulder ProsthesisTornier · 2008 · 3 generations on179descendants
  • K071948Aequalis Reversed AdapterTornier · 2007 · 4 generations on178descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K873679Select Shoulder SystemIntermedics Orthopedics1987—
+1K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004—
+2K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006—
+3K061439Aequalis Reversed ProsthesisTornier2006—
+3K081059Aequalis Reversed Shoulder ProsthesisTornier2008—
+4K071948Aequalis Reversed AdapterTornier2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200650
200720
200830
201050
2011100
201270
201380
2014110
201560
2016120
2017140
2018170
2019200
2020180
2021220
2022220
2023170
2024160
2025210
2026220
FIG. 1 — Lineage of K873679, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · 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 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
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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? (259)

See all 259

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004258

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, K043077 (Tornier, 2004) has gone furthest, with 258 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—

More from Intermedics Orthopedics

108 FDA decisions under this applicant name. See the company

  • K970300Natural-Hip System Porous Stem with HA/CstiIntermedics Orthopedics · 1997
  • K970498Natural-Knee II Revision Femoral Spacer LugsIntermedics Orthopedics · 1997
  • K970166Natural-Hip System Cocr Revision StemIntermedics Orthopedics · 1997
  • K970567Select Shoulder Curved-Back Pegged All Poly GlenoidsIntermedics Orthopedics · 1997
  • K964357Natural-Hip System Cocr StemIntermedics Orthopedics · 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/K873679 · printed Nov 4, 2026

Cite this page

510(k) Report. “K873679: Select Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873679

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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