510(k) Report

510(k) · Cleared

Cleared

GRS Glenoid Resurfacing System

K091196510(k) TraditionalCleared Oct 27, 2009187-day reviewClass II21 CFR 888.3660

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

Arthrosurface, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Oct 27, 2009 as substantially equivalent to K981487 (DePuy Orthopaedics, Inc., 1998) and 2 other predicates after a 187-day review. Its family tree reaches back 5 generations to 1980. 23 later devices descend from it.

Decided
Oct 27, 2009
Review
187 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K800494 (1980). 28 ancestors in all. 23 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor1998: 2 other ancestors2005: 1 other ancestor2004: 3 other ancestors2003: 1 other ancestor2002: 1 other ancestor1999: 2 other ancestors2001: 1 other ancestor1994: 2 other ancestors1992: 2 other ancestors1991: 1 other ancestor1987: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors1980: 1 other ancestor2016: 1 descendant cleared2021: 2 descendants cleared2026: 6 descendants cleared2018: 3 descendants cleared2019: 2 descendants cleared2023: 1 descendant cleared2022: 5 descendants cleared2024: 1 descendant cleared2025: 2 descendants clearedK800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980K991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK030710 · Bio-Modular Shoulder System · Biomet, Inc. · 2003 · recalledK060694 · Modular Hybrid Glenoid · Biomet Manufacturing Corp · 2006 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 9 other ancestors4 generations back: 6 other ancestors5 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 9 descendants3 generations forward: 8 descendants4 generations forward: 3 descendants K060694 · Modular Hybrid Glenoid · Biomet Manufacturing Corp · 2006 · recalledK030710 · Bio-Modular Shoulder System · Biomet, Inc. · 2003 · recalledK002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980−50
  1. Root · 5 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
  2. 4 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
  3. 3 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
  4. 2 generations backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
  5. 1 generation backK060694 Modular Hybrid GlenoidBiomet Manufacturing Corp · 2006 · Recalled
  6. This deviceK091196 GRS Glenoid Resurfacing SystemArthrosurface, Inc. · 2009
  7. Descendant · cites it directly · 13 of its ownK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
  8. Descendant · 2 generations on · 9 of its ownK212737 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
  9. Descendant · cites it directly · 7 of its ownK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
  10. Descendant · 2 generations on · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
  11. Descendant · 2 generations on · 3 of its ownK181287 Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2016: 12018: 32019: 22021: 22022: 52023: 12024: 12025: 22026: 6
2016high 6 (2026) · low 0 (2017)2026

Most influential descendants

Showing 5 of 23 · See all
  • K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly13descendants
  • K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022 · 2 generations on9descendants
  • K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016 · cites it directly7descendants
  • K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · 2 generations on3descendants
  • K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2018 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K800494New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc.1980—
−4K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999—
−3K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20001
−2K030710Bio-Modular Shoulder SystemBiomet, Inc.20031
−1K060694Modular Hybrid GlenoidBiomet Manufacturing Corp20064
0 (this device)K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.2009—
+1K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC2021—
+2K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC2022—
+1K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC2016—
+2K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC2021—
+2K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198710
199110
199220
199420
199520
199610
199710
199820
199920
200110
200210
200310
200430
200510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201830
201920
202120
202250
202310
202410
202520
202660
FIG. 1 — Lineage of K091196, 1980–2026Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWS? 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 KWS device

  1. #1 K220847 AETOS Shoulder Systemscore 21.1 · 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? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K981487Depuy Global Shoulder Glenoid
Summary page 2
…Device are substantially equivalent to the following previously cleared and commercially marketed devices: * DePuy Global TM Shoulder Glenoid Component K981487 · Biomet Modular Hybrid Glenoid K060694 * Synthes Epoca Shoulder Prosthesis System…
DePuy Orthopaedics, Inc.1998—
*K060694Modular Hybrid Glenoid
Summary page 2
…d and commercially marketed devices: * DePuy Global TM Shoulder Glenoid Component K981487 · Biomet Modular Hybrid Glenoid K060694 * Synthes Epoca Shoulder Prosthesis System K072578 DEPARTMENT OF HEALTH & HUMAN SERVICES…
Biomet Manufacturing Corp20064
*K072578Synthes (Usa) Epoca Shoulder Prosthesis System
Summary page 2
…Glenoid Component K981487 · Biomet Modular Hybrid Glenoid K060694 * Synthes Epoca Shoulder Prosthesis System K072578 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…
Synthes (Usa)2007—

Also cleared against K981487: 11 other devices →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113
K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167
K260721Tornier Perform Advanced GlenoidTornier, Inc.20260

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?

  • The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
  • 10 of the 28 ancestors have a recall of any class.
  • Of its descendants, K202716 (Ignite Orthopedics, LLC, 2021) has gone furthest, with 13 descendants of its own.
  • 11 other devices also cite its predicate K981487.

How does its category compare?

All KWS devices

KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KWS

3in 2025

2007: 22008: 42009: 42010: 72011: 112012: 72013: 122014: 72015: 82016: 102017: 72018: 42019: 92020: 32021: 52022: 52023: 42024: 22025: 32026 (partial year): 2
2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2008: 37 days median2009: 108 days median2010: 33 days median2011: 90 days median2012: 86 days median2013: 120 days median2014: 89 days median2015: 129 days median2016: 114 days median2017: 120 days median2018: 152 days median2019: 106 days median2020: 98 days median2021: 151 days median2022: 158 days median2023: 250 days median2025: 97 days median
2007high 250 (2023) · low 33 (2010)2026

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

Recalls per year · KWS

2in 2023

2007: 212008: 292010: 102011: 112012: 102014: 12016: 12017: 42018: 12019: 22020: 52023: 22026 (partial year): 1
2007high 29 (2008) · low 0 (2009)2026

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

Adverse event reports per year · KWS

2,281in 2025

2007: 1582008: 2382009: 2942010: 3932011: 4862012: 5422013: 8182014: 1,0662015: 1,1702016: 9702017: 1,6812018: 1,5452019: 1,7282020: 1,5672021: 1,3582022: 1,2682023: 1,7502024: 2,1222025: 2,281
2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, 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
20072—21158
200843729238
200941080294
201073310393
2011119011486
201278610542
2013121200818
201478911,066
2015812901,170
2016101141970
2017712041,681
2018415211,545
2019910621,728
202039851,567
2021515101,358
2022515801,268
2023425021,750
20242—02,122
202539702,281
20262—1—

What is it indicated for?

For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid vault should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K981487

11 other devices cite the same predicate.

  • K203230Global Shoulder and Delta CTA systemsDepuy Lnc. · 2021
  • K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc. · 2019
  • K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. · 2018
  • K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
  • K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013
  • K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A. · 2012

More from Arthrosurface, Inc.

26 FDA decisions under this applicant name. See the company

  • K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc. · 2021
  • K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. · 2020
  • K190261BOSS Toe Fixation SystemArthrosurface, Inc. · 2019
  • K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. · 20183 recalls
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

Recent decisions in KWS

The KWS category page

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
  • K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  • K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A. · 2025

https://510kreport.com/device/K091196 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091196: GRS Glenoid Resurfacing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091196

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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