510(k) Report

510(k) · Cleared

Cleared

Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies,

K101263510(k) TraditionalCleared Jan 28, 2011268-day reviewClass II21 CFR 888.3650

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

Lima-Lto S.P.A. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Cleared on Jan 28, 2011 as substantially equivalent to K032126 (Plus Orthopedics, 2004) and 3 other predicates after a 268-day review. Its family tree reaches back 3 generations to 1987. 38 later devices descend from it.

Decided
Jan 28, 2011
Review
268 days
Class
Class II
Product code
KWT
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K873073 (1987). 15 ancestors in all. 38 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2001: 3 other ancestors1999: 2 other ancestors1996: 1 other ancestor1995: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor2011: 2 descendants cleared2021: 5 descendants cleared2016: 1 descendant cleared2019: 4 descendants cleared2012: 1 descendant cleared2013: 3 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2017: 2 descendants cleared2020: 2 descendants cleared2023: 6 descendants cleared2022: 3 descendants cleared2025: 3 descendants cleared2026: 2 descendants cleared2024: 1 descendant clearedK873073 · Kirschner Neer-Iii Proximal Humerus · Kirschner Medical Corp. · 1987K961260 · Kirschner Sholders with Titanium Plasma Spray · Biomet, Inc. · 1997K992525 · Acumed Modular Shoulder System · Acu Med, Inc. · 2000 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 3 other ancestors 1 generation forward: 9 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 3 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K992525 · Acumed Modular Shoulder System · Acu Med, Inc. · 2000 · recalledK961260 · Kirschner Sholders with Titanium Plasma Spray · Biomet, Inc. · 1997K873073 · Kirschner Neer-Iii Proximal Humerus · Kirschner Medical Corp. · 19870+5
  1. Root · 3 generations backK873073 Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp. · 1987
  2. 2 generations backK961260 Kirschner Sholders with Titanium Plasma SprayBiomet, Inc. · 1997
  3. 1 generation backK992525 Acumed Modular Shoulder SystemAcu Med, Inc. · 2000 · Recalled
  4. This deviceK101263 Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR…Lima-Lto S.P.A. · 2011
  5. Descendant · cites it directly · 34 of its ownK110847 SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011
  6. Descendant · cites it directly · 33 of its ownK111212 SMR Shoulder System- Revision StemsLima Corporate S.P.A. · 2011
  7. Descendant · cites it directly · 31 of its ownK113254 SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A. · 2012
  8. Descendant · 2 generations on · 20 of its ownK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
  9. Descendant · cites it directly · 14 of its ownK130642 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2013

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12013: 32014: 12015: 12016: 12017: 22018: 12019: 42020: 22021: 52022: 32023: 62024: 12025: 32026: 2
2011high 6 (2023) · low 1 (2012)2026

Most influential descendants

Showing 5 of 38 · See all
  • K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011 · cites it directly34descendants
  • K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A. · 2011 · cites it directly33descendants
  • K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A. · 2012 · cites it directly31descendants
  • K133349SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014 · 2 generations on20descendants
  • K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2013 · cites it directly14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K873073Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp.1987—
−2K961260Kirschner Sholders with Titanium Plasma SprayBiomet, Inc.1997—
−1K992525Acumed Modular Shoulder SystemAcu Med, Inc.20001
0 (this device)K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder…Lima-Lto S.P.A.2011—
+1K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.2011—
+1K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.2011—
+1K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A.2012—
+2K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.2014—
+1K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198810
199510
199610
199920
200130
200310
200410
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201330
201410
201510
201610
201720
201810
201940
202020
202150
202230
202360
202410
202530
202620
FIG. 1 — Lineage of K101263, 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), 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 KWT? 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. #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 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
*K032126Promos Shoulder
Summary page 3
…fractures of the humneral head that cannot be treated with other fracture fixation methods Predicate Devices: * Promos modular shoulder system (PlusOrthopedics, K032 126, K063578); * Anatomical shoulder system (Centerpulse, K030259); *Modular Shoulder System (Acumed, K992525) Comparable Fe…
Plus Orthopedics2004—
*K063578Promos Modular Shoulder System
Summary page 3
…of the humneral head that cannot be treated with other fracture fixation methods Predicate Devices: * Promos modular shoulder system (PlusOrthopedics, K032 126, K063578); * Anatomical shoulder system (Centerpulse, K030259); *Modular Shoulder System (Acumed, K992525) Comparable Features to…
Plus Orthopedics AG20074
*K030259Amatomical Shoulder with Removable Head
Summary page 3
…racture fixation methods Predicate Devices: * Promos modular shoulder system (PlusOrthopedics, K032 126, K063578); * Anatomical shoulder system (Centerpulse, K030259); *Modular Shoulder System (Acumed, K992525) Comparable Features to Predicate Device(s): The SMR Shoulder System is similar…
Centerplus Orthopedics, Inc.20033
*K992525Acumed Modular Shoulder System
Summary page 3
…* Promos modular shoulder system (PlusOrthopedics, K032 126, K063578); * Anatomical shoulder system (Centerpulse, K030259); *Modular Shoulder System (Acumed, K992525) Comparable Features to Predicate Device(s): The SMR Shoulder System is similar to the predicate devices in terms of intended u…
Acu Med, Inc.20001

Also cleared against K032126: 4 other devices →

What descends from it? (38)

See all 38

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

NumberDeviceApplicantDecidedDescendants
K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.201134
K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133
K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231
K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314
K191963SMR Finned Short StemsLima Corporate S.P.A.201913
K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613
K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213
K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210
K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190

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 4 companies; a new generation was cleared every 9.5 years on median.
  • 5 of the 15 ancestors have a recall of any class.
  • Of its descendants, K110847 (Lima Corporate S.P.A., 2011) has gone furthest, with 34 descendants of its own.
  • 4 other devices also cite its predicate K032126.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · KWT

4in 2025

2007: 12010: 12011: 52012: 12013: 12014: 12015: 22016: 22017: 12018: 22019: 42020: 12021: 12022: 12023: 12024: 12025: 42026 (partial year): 1
2007high 5 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWT

242in 2025

2011: 165 days median2019: 91 days median2025: 242 days median
2007high 242 (2025) · low 91 (2019)2026

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

Recalls per year · KWT

1in 2023

2008: 12010: 72012: 22013: 12016: 12017: 12018: 12019: 32023: 1
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

2007: 322008: 482009: 582010: 712011: 1122012: 832013: 1132014: 1682015: 1762016: 4452017: 5602018: 4802019: 4192020: 2152021: 2282022: 2732023: 3612024: 6012025: 749
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—032
20080—148
20090—058
20101—771
201151650112
20121—283
20131—1113
20141—0168
20152—0176
20162—1445
20171—1560
20182—1480
20194913419
20201—0215
20211—0228
20221—0273
20231—1361
20241—0601
202542420749
20261—0—

What is it indicated for?

The SMR Shoulder system is intended for partial or total primary shoulder joint replacement.

The components are intended for use in cemented and uncemented applications, as specified in the following table:

Total or hemi-shoulder replacement is indicated for patients suffering from disability due to:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

* Inflammatory degenerative joint disease such as rheumatoid arthritis;

* Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods

Indications for use as stated in the FDA summary.

Also cleared against K032126

4 other devices cite the same predicate.

  • K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc. · 2012
  • K100448Ascension Modular Total Shoulder SystemAscension Orthopedics, Inc. · 20101 recall
  • K063578Promos Modular Shoulder SystemPlus Orthopedics AG · 20074 recalls
  • K042021Exactech Equinoxe Shoulder SystemExactech, Inc. · 200410 recalls

More from Lima-Lto S.P.A.

2 FDA decisions under this applicant name. See the company

  • K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies,Lima-Lto S.P.A. · 20102 recalls

Recent decisions in KWT

The KWT category page

  • K262173N22 Offset Humeral HeadShoulder Innovations, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 20251 recall
  • K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2025
  • K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025

https://510kreport.com/device/K101263 · printed Nov 3, 2026

Cite this page

510(k) Report. “K101263: Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101263

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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