510(k) Report

510(k) · Cleared

Cleared

SMR Lateralized Connectors with screws

K183042510(k) TraditionalCleared Jan 25, 201984-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

Lima Corporate S.P.A. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Jan 25, 2019 as substantially equivalent to K100858 (Lima-Lto S.P.A., 2010) and 14 other predicates after an 84-day review. Its family tree reaches back 15 generations to 1991. 1 of the 250 devices in its family, counting itself, has a Class I recall.

Decided
Jan 25, 2019
Review
84 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
15

Its longest line of descent runs back 15 generations to K911686 (1991). 249 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 250 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2017: 1 other ancestor2016: 3 other ancestors2014: 4 other ancestors2012: 4 other ancestors2011: 9 other ancestors2010: 5 other ancestors2009: 3 other ancestors2005: 12 other ancestors2013: 4 other ancestors2008: 8 other ancestors2007: 10 other ancestors2006: 7 other ancestors2004: 10 other ancestors2003: 8 other ancestors2000: 20 other ancestors1999: 11 other ancestors2002: 4 other ancestors2001: 11 other ancestors1998: 11 other ancestors1997: 7 other ancestors1996: 14 other ancestors1995: 19 other ancestors1994: 18 other ancestors1992: 5 other ancestors1987: 5 other ancestors1985: 3 other ancestors1991: 2 other ancestors1988: 1 other ancestor1980: 2 other ancestors1993: 6 other ancestors1989: 1 other ancestor1986: 3 other ancestors1981: 1 other ancestor1979: 1 other ancestor1990: 1 other ancestorK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K021478 · Delta Shoulder · Depuy, Inc. · 2003×2: 2 generations cleared close together, K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) K120174 · Deput Delta Xtend Reverse Shoulder · Depuy France · 2012 · recalledK133349 · SMR TT Metal Back Glenoid · Lima Corporate S.P.A. · 2014K161120 · SMR TT Metal Back Glenoid, Bone Graft instruments · Lima Corporate S.P.A. · 2017K172456 · Bone Screws 6.5mm · Lima Corporate S.P.A. · 2018 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 13 other ancestors2 generations back: 27 other ancestors3 generations back: 59 other ancestors4 generations back: 35 other ancestors5 generations back: 32 other ancestors6 generations back: 31 other ancestors7 generations back: 19 other ancestors8 generations back: 15 other ancestors9 generations back: 3 other ancestors K172456 · Bone Screws 6.5mm · Lima Corporate S.P.A. · 2018 · recalledK161120 · SMR TT Metal Back Glenoid, Bone Graft instruments · Lima Corporate S.P.A. · 2017K133349 · SMR TT Metal Back Glenoid · Lima Corporate S.P.A. · 2014K120174 · Deput Delta Xtend Reverse Shoulder · Depuy France · 2012 · recalledK080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−15−10−50
  1. Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 11 generations between
  3. 3 generations backK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
  4. 2 generations backK161120 SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A. · 2017
  5. 1 generation backK172456 Bone Screws 6.5mmLima Corporate S.P.A. · 2018 · Recalled
  6. This deviceK183042 SMR Lateralized Connectors with screwsLima Corporate S.P.A. · 2019
Show all 15 generations
  1. Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 14 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 13 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 12 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 11 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 10 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 9 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 8 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 7 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 6 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 5 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 4 generations backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
  13. 3 generations backK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
  14. 2 generations backK161120 SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A. · 2017
  15. 1 generation backK172456 Bone Screws 6.5mmLima Corporate S.P.A. · 2018 · Recalled
  16. This deviceK183042 SMR Lateralized Connectors with screwsLima Corporate S.P.A. · 2019

Class I recalls in this family

View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−14K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−13K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−12K021478Delta ShoulderDepuy, Inc.2003—
−11K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−10K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−9K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−8K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−7K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−6K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−5K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−4K120174Deput Delta Xtend Reverse ShoulderDepuy France20122
−3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.2014—
−2K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.2017—
−1K172456Bone Screws 6.5mmLima Corporate S.P.A.20182
0 (this device)K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198110
198530
198630
198750
198810
198910
199010
199120
199250
199360
1994180
1995190
1996140
199770
1998110
1999110
2000200
2001110
200240
200380
2004100
2005120
200670
2007100
200880
200930
201050
201190
201240
201340
201440
201630
201710
FIG. 1 — Lineage of K183042, 1991–2019Source: 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.

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 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
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What was it cleared against? (15)

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
*K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…
Summary page 7
…redicate Devices: Company Device name Cleared via Limacorporate SMR Reverse Shoulder System K100858, K101263, K110598, K111212,…
Lima-Lto S.P.A.20102
*K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…
Summary page 7
…Devices: Company Device name Cleared via Limacorporate SMR Reverse Shoulder System K100858, K101263, K110598, K111212,…
Lima-Lto S.P.A.2011—
*K110598SMR Reverse Shoulder System
Summary page 7
…Cleared via Limacorporate SMR Reverse Shoulder System K100858, K101263, K110598, K111212, K113254, K133349,…
Lima Corporate S.P.A.20111
*K111212SMR Shoulder System- Revision Stems
Summary page 7
…ia Limacorporate SMR Reverse Shoulder System K100858, K101263, K110598, K111212, K113254, K133349,…
Lima Corporate S.P.A.2011—
*K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws
Summary page 7
…8, K101263, K110598, K111212, K113254, K133349, K142139, K163397,…
Lima Corporate S.P.A.2012—
*K133349SMR TT Metal Back Glenoid
Summary page 7
…3, K110598, K111212, K113254, K133349, K142139, K163397,…
Lima Corporate S.P.A.2014—
*K142139SMR 40MM Glenosphere
Summary page 7
…8, K111212, K113254, K133349, K142139, K163397, K172456 DJO Surgical (legally RSP Reverse S…
Lima Corporate S.P.A.2014—
*K163397SMR Hybrid Glenoid System
Summary page 7
…2, K113254, K133349, K142139, K163397, K172456 DJO Surgical (legally RSP Reverse Shoulder P…
Lima Corporate S.P.A.20171
*K172456Bone Screws 6.5mm
Summary page 7
…4, K133349, K142139, K163397, K172456 DJO Surgical (legally RSP Reverse Shoulder Prosthesis K092873, K112069, Encore Medical, L.P.)…
Lima Corporate S.P.A.20182
*K092873Reverse Shoulder Prosthesis
Summary page 7
…K142139, K163397, K172456 DJO Surgical (legally RSP Reverse Shoulder Prosthesis K092873, K112069, Encore Medical, L.P.) K041066, K051075,…
Djo Surgical2009—
*K112069RSP Glenoid Baseplate Porous Coated
Summary page 7
…39, K163397, K172456 DJO Surgical (legally RSP Reverse Shoulder Prosthesis K092873, K112069, Encore Medical, L.P.) K041066, K051075,…
Encore Medical L.P.20111
*K041066Encore Reverse Shoulder Prosthesis
Summary page 7
…K172456 DJO Surgical (legally RSP Reverse Shoulder Prosthesis K092873, K112069, Encore Medical, L.P.) K041066, K051075, K141006 Tornier Aequalis PerF…
Encore Medical L.P.20054
*K051075Encore Reverse Shoulder Prosthesis
Summary page 7
…56 DJO Surgical (legally RSP Reverse Shoulder Prosthesis K092873, K112069, Encore Medical, L.P.) K041066, K051075, K141006 Tornier Aequalis PerFORM Rever…
Encore Medical L.P.20055
*K141006RSP Humeral Socket Insert
Summary page 7
…3, K112069, Encore Medical, L.P.) K041066, K051075, K141006 Tornier Aequalis PerFORM Reversed & K161742 Aequalis PerFORM+ Rever…
Djo Global20142
*K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
Summary page 7
…K041066, K051075, K141006 Tornier Aequalis PerFORM Reversed & K161742 Aequalis PerFORM+ Reversed Glenoid Traditional 510(k) – SMR Lateralized Connectors with screws…
Tornier, Inc.20163

Also cleared against K100858: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
  • 81 of the 249 ancestors have a recall of any class; 1 has a Class I recall.
  • 8 other devices also cite its predicate K100858.

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. 2019, 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?

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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…

Read the full statement (594 words)

The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in 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;

* revision of a failed primary implant;

* cuff tear arthropathy (CTA Heads only);

* glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR Hybrid Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.

The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.

On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.

System Use

A=Anatomic / R=Reverse

* In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.

* The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.

* SMR lateralized connectors are not indicated for use with glenoid bone grafting techniques.

* In the US the SMR TT Metal Back Baseplate used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.

* If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the polyethylene baseplate, leaving the metal peg in place and by connecting it to the SMR Hybrid Glenoid Reverse Baseplate. The SMR Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.

* The Dia. 50, 52 and 54 mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).

* The Dia. 52 and 54 mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).

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

Cite this page

510(k) Report. “K183042: SMR Lateralized Connectors with screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183042

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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