510(k) Report

510(k) · Cleared

Cleared

Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral Heads

K030344510(k) SpecialCleared Mar 4, 200329-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

Smith & Nephew, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Mar 4, 2003 as substantially equivalent to K955767 (Smith & Nephew Richards, Inc., 1996) and 3 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1979.

Decided
Mar 4, 2003
Review
29 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K790987 (1979). 15 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1996: 5 other ancestors1995: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor1989: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestorK790987 · Zimmer R Total Shoulder II · Zimmer, Inc. · 1979K982981 · New Zimmer Shoulder System · Zimmer, Inc. · 1998 · recalled1975198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors K982981 · New Zimmer Shoulder System · Zimmer, Inc. · 1998 · recalledK790987 · Zimmer R Total Shoulder II · Zimmer, Inc. · 19790
  1. Root · 2 generations backK790987 Zimmer R Total Shoulder IIZimmer, Inc. · 1979
  2. 1 generation backK982981 New Zimmer Shoulder SystemZimmer, Inc. · 1998 · Recalled
  3. This deviceK030344 Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral HeadsSmith & Nephew, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K790987Zimmer R Total Shoulder IIZimmer, Inc.1979—
−1K982981New Zimmer Shoulder SystemZimmer, Inc.19981
0 (this device)K030344Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral HeadsSmith & Nephew, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
198910
199210
199310
199520
199650
200110
FIG. 1 — Lineage of K030344, 1979–2003Source: 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? (4)

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
*K955767Cofied Modular Shoulder System
Summary page 1
…ted Devices Modu!ar Neer 3 Humeral Stems and Humeral Heads are substantially equivalent to Smith & Nephew Cofield2 Total Shoulder System humeral stems and humeral heads (K955767 and K003566), Tornier, S.A. AequalisTMShoulder System (K952928), and the New Zimmer Shoulder System (K98298 1). Devic,eDescripti…
Smith & Nephew Richards, Inc.1996—
*K003566Cofield Eccentric and Lateral Offset Humeral Heads
Summary page 1
…Modu!ar Neer 3 Humeral Stems and Humeral Heads are substantially equivalent to Smith & Nephew Cofield2 Total Shoulder System humeral stems and humeral heads (K955767 and K003566), Tornier, S.A. AequalisTMShoulder System (K952928), and the New Zimmer Shoulder System (K98298 1). Devic,eDescription The subje…
Smith & Nephew, Inc.2001—
*K952928Aequalis Shoulder System for Total & Hemishoulder Applications
Summary page 1
…substantially equivalent to Smith & Nephew Cofield2 Total Shoulder System humeral stems and humeral heads (K955767 and K003566), Tornier, S.A. AequalisTMShoulder System (K952928), and the New Zimmer Shoulder System (K98298 1). Devic,eDescription The subject devices are modular humeral stems and humeral he…
Tornier1995—
*K982981New Zimmer Shoulder System
Summary page 1
…ield2 Total Shoulder System humeral stems and humeral heads (K955767 and K003566), Tornier, S.A. AequalisTMShoulder System (K952928), and the New Zimmer Shoulder System (K98298 1). Devic,eDescription The subject devices are modular humeral stems and humeral heads. They are designed for use with existing Ne…
Zimmer, Inc.19981

Also cleared against K955767: 4 other devices →

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.

What does this lineage say?

  • The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 19.5 years on median.
  • 3 of the 15 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K955767.

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.

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?

Modular Neer 3 Humeral Stems and Humeral Heads are indicated for use as orthopedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. Modular Neer 3 Humeral Stems and Humeral Heads are intended for use with bone cement (cemented fixation) and for single use only. Modular Neer 3 Humeral Stems and Humeral Heads are intended for the…

Read the full statement (220 words)

Modular Neer 3 Humeral Stems and Humeral Heads are indicated for use as orthopedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. Modular Neer 3 Humeral Stems and Humeral Heads are intended for use with bone cement (cemented fixation) and for single use only. Modular Neer 3 Humeral Stems and Humeral Heads are intended for the following indications:

Proximal Humeral Prosthesis - (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.

Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) - severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.

Indications for use as stated in the FDA summary.

Also cleared against K955767

4 other devices cite the same predicate.

  • K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc. · 2012
  • K113012Promos Modular Shoulder SystemSmith & Nephew, Inc. · 2012
  • K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd.Exactech, Inc. · 20101 recall
  • K070565Cofield Total Shoulder SystemSmith & Nephew, Inc. · 2007

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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/K030344 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030344: Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030344

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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