510(k) · Cleared

Recalled · Class II · 2019

New Zimmer Shoulder System

K982981510(k) TraditionalCleared Dec 17, 1998113-day reviewClass II21 CFR 888.3650Recalls 1

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

Zimmer, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Cleared on Dec 17, 1998 as substantially equivalent to K852137 (Zimmer, Inc., 1986) and 10 other predicates after a 113-day review. Its family tree reaches back 1 generation to 1979. 1 of the 247 devices in its family, counting itself, has a Class I recall. 235 later devices descend from it. It has been recalled once.

Decided: Dec 17, 1998
Review: 113 days
Class: Class II
Product code: KWT
Recalls: 1
Predicates: 11

Its longest line of descent runs back 1 generation to K790987 (1979). 11 ancestors in all. 235 later devices descend from it, 7 citing it directly. 1 of the 247 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK790987 Zimmer R Total Shoulder IIZimmer, Inc. · 1979
This deviceK982981 New Zimmer Shoulder SystemZimmer, Inc. · 1998
Descendant · cites it directly · 218 of its ownK041549 Zimmer Trabecular Metal Humeral StemZimmer, Inc. · 2004 · Recalled
Descendant · 2 generations on · 216 of its ownK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
Descendant · 3 generations on · 207 of its ownK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
Descendant · 3 generations on · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
Descendant · 4 generations on · 177 of its ownK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled

Showing 5 of 235 descendants. See all descendants

Descendants cleared per year

2003high 22 (2021) · low 0 (2009)2026

Class I recalls in this family

K080642 Comprehensive Reverse Shoulder3 generations on · 2008

Most influential descendants

Showing 5 of 235 · See all

K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc. · 2004 · cites it directly218descendants
K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · 2 generations on216descendants
K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · 3 generations on207descendants
K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · 3 generations on190descendants
K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc. · 2008 · 4 generations on177descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K790987	Zimmer R Total Shoulder II	Zimmer, Inc.	1979	—
0 (this device)	K982981	New Zimmer Shoulder System	Zimmer, Inc.	1998	—
+1	K041549	Zimmer Trabecular Metal Humeral Stem	Zimmer, Inc.	2004	8
+2	K052906	Zimmer Trabecular Metal Reverse Shoulder System	Zimmer, Inc.	2005	12
+3	K060704	Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM	Zimmer, Inc.	2006	10
+3	K063569	Equinoxe Reverse Shoulder System	Exactech, Inc.	2007	13
+4	K073688	Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw	Exactech, Inc.	2008	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1987	1	0
1989	1	0
1992	1	0
1993	1	0
1995	1	0
1996	4	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	2	0
2006	2	0
2007	2	0
2008	3	1
2010	5	0
2011	9	0
2012	9	0
2013	11	0
2014	10	0
2015	6	0
2016	7	0
2017	15	0
2018	12	0
2019	17	0
2020	20	0
2021	22	0
2022	18	0
2023	15	0
2024	14	0
2025	15	0
2026	19	0

FIG. 1 — Lineage of K982981, 1979–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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 KWT device

#1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (11)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K852137	Fenlin Total Shoulder Summary page 1 …Summary The New Zimmer Shoulder System utilizes design features common to one or more of the following devices: Device K Number(s) Decision Date Fenlin Total Shoulder K852137 2/12/86 Fenlin RCD Total Shoulder K870262 4/3/87 Zimmer Total Shoulder I1 K790987 6/22/79 3-M Neer II Shoulder Prosthesis K895226…	Zimmer, Inc.	1986	—
*	K870262	Fenlin II Shoulder Prosthesis Summary page 1 …tilizes design features common to one or more of the following devices: Device K Number(s) Decision Date Fenlin Total Shoulder K852137 2/12/86 Fenlin RCD Total Shoulder K870262 4/3/87 Zimmer Total Shoulder I1 K790987 6/22/79 3-M Neer II Shoulder Prosthesis K895226 11/3/89 PAYN WA A Bristol-Myers Squibb C…	Zimmer, Inc.	1987	—
*	K790987	Zimmer R Total Shoulder II Summary page 1 …more of the following devices: Device K Number(s) Decision Date Fenlin Total Shoulder K852137 2/12/86 Fenlin RCD Total Shoulder K870262 4/3/87 Zimmer Total Shoulder I1 K790987 6/22/79 3-M Neer II Shoulder Prosthesis K895226 11/3/89 PAYN WA A Bristol-Myers Squibb Company Ll Summary of Sa…	Zimmer, Inc.	1979	—
*	K895226	Neer II Total Shoulder System & Prosthesis Summary page 1 …(s) Decision Date Fenlin Total Shoulder K852137 2/12/86 Fenlin RCD Total Shoulder K870262 4/3/87 Zimmer Total Shoulder I1 K790987 6/22/79 3-M Neer II Shoulder Prosthesis K895226 11/3/89 PAYN WA A Bristol-Myers Squibb Company Ll Summary of Safety and Effectiveness New Zimmer Shoulder Syste…	3M Company	1989	—
*	K920362	3M Modular Shoulder System Summary page 2 …b Company Ll Summary of Safety and Effectiveness New Zimmer Shoulder System {Continued) Device K Number(s) Decision Date \| 3-M Modular Shoulder System K920362 7/22/93 Osteonics Shoulder Components K955731 3/5/96 K962082 8/13/96 Kirschner Modular II-C Total Shoulder System K940537 8/29/9…	3M Health Care, Ltd.	1993	—
*	K955731	Osteonics Shoulder Humeral Components Summary page 2 …y and Effectiveness New Zimmer Shoulder System {Continued) Device K Number(s) Decision Date \| 3-M Modular Shoulder System K920362 7/22/93 Osteonics Shoulder Components K955731 3/5/96 K962082 8/13/96 Kirschner Modular II-C Total Shoulder System K940537 8/29/95 Intermedics Select Shoulder K962315 9/3/96 K…	Osteonics Corp.	1996	1
*	K962082	Osteonics All Polyethylene Glenoid Shoulder Component Summary page 2 …ness New Zimmer Shoulder System {Continued) Device K Number(s) Decision Date \| 3-M Modular Shoulder System K920362 7/22/93 Osteonics Shoulder Components K955731 3/5/96 K962082 8/13/96 Kirschner Modular II-C Total Shoulder System K940537 8/29/95 Intermedics Select Shoulder K962315 9/3/96 K962238 8/9/96…	Osteonics Corp.	1996	1
*	K940537	Kirschner (R) Modular II-C (TM) Total Shoulder System Summary page 2 …) Decision Date \| 3-M Modular Shoulder System K920362 7/22/93 Osteonics Shoulder Components K955731 3/5/96 K962082 8/13/96 Kirschner Modular II-C Total Shoulder System K940537 8/29/95 Intermedics Select Shoulder K962315 9/3/96 K962238 8/9/96 DePuy Global Total Shoulder K914695 1/16/92 Device Descriptio…	Kirschner Medical Corp.	1995	—
*	K962315	Select Shoulder Cocr Humeral Stem Component Summary page 2 …em K920362 7/22/93 Osteonics Shoulder Components K955731 3/5/96 K962082 8/13/96 Kirschner Modular II-C Total Shoulder System K940537 8/29/95 Intermedics Select Shoulder K962315 9/3/96 K962238 8/9/96 DePuy Global Total Shoulder K914695 1/16/92 Device Description The New Zimmer Shoulder features modular…	Intermedics Orthopedics	1996	—
*	K962238	Select Shoulder Keeled All-Poly Glenoids Summary page 2 …/93 Osteonics Shoulder Components K955731 3/5/96 K962082 8/13/96 Kirschner Modular II-C Total Shoulder System K940537 8/29/95 Intermedics Select Shoulder K962315 9/3/96 K962238 8/9/96 DePuy Global Total Shoulder K914695 1/16/92 Device Description The New Zimmer Shoulder features modular and monoblock c…	Intermedics Orthopedics	1996	—
*	K914695	Global Total Shoulder Summary page 2 …5/96 K962082 8/13/96 Kirschner Modular II-C Total Shoulder System K940537 8/29/95 Intermedics Select Shoulder K962315 9/3/96 K962238 8/9/96 DePuy Global Total Shoulder K914695 1/16/92 Device Description The New Zimmer Shoulder features modular and monoblock cobalt-chrome alloy humeral stems intended fo…	Depuy, Inc.	1992	—

What descends from it? (235)

See all 235

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

Number	Device	Applicant	Decided	Descendants
K041549	Zimmer Trabecular Metal Humeral Stem	Zimmer, Inc.	2004	218
K102670	Total Shoulder System	Shoulder Innovations, LLC	2011	18
K111596	Total Shoulder System	Shoulder Innovations, LLC	2011	15
K171858	Sidus Stem-Free Shoulder	Zimmer GmbH	2017	13
K103404	ANA0TOMICAL Shoulder TM Combined System	Zimmer GmbH	2011	3
K110791	Bigliani / Flatow (R) the Complete Shoulder Solution	Zimmer, Inc.	2011	0
K030344	Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral Heads	Smith & Nephew, Inc.	2003	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 10, 2019	Class II	Z-0298-2020	Packaging change control	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

2 of the 11 ancestors have a recall of any class.
Of its descendants, K041549 (Zimmer, Inc., 2004) has gone furthest, with 218 descendants of its own.

How does its category compare?

All KWT devices

KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWT

4in 2025

2007high 5 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWT

242in 2025

2007high 242 (2025) · low 91 (2019)2026

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

Recalls per year · KWT

1in 2023

2007high 7 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWT

749in 2025

2007high 749 (2025) · low 32 (2007)2025

MAUDE reports naming product code KWT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	32
2008	0	—	1	48
2009	0	—	0	58
2010	1	—	7	71
2011	5	165	0	112
2012	1	—	2	83
2013	1	—	1	113
2014	1	—	0	168
2015	2	—	0	176
2016	2	—	1	445
2017	1	—	1	560
2018	2	—	1	480
2019	4	91	3	419
2020	1	—	0	215
2021	1	—	0	228
2022	1	—	0	273
2023	1	—	1	361
2024	1	—	0	601
2025	4	242	0	749
2026	1	—	0	—

What is it indicated for?

Read the full statement (110 words)

Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982981 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982981: New Zimmer Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982981

Report an extraction error

Are you the manufacturer?

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