510(k) Report

510(k) · Cleared

Cleared

SMR 140° Reverse Humeral Body

K201905510(k) TraditionalCleared Dec 17, 2020161-day reviewClass II21 CFR 888.3670

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. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Dec 17, 2020 as substantially equivalent to K191963 (Lima Corporate S.P.A., 2019) and 5 other predicates after a 161-day review. Its family tree reaches back 15 generations to 1991. 1 of the 149 devices in its family, counting itself, has a Class I recall.

Decided
Dec 17, 2020
Review
161 days
Class
Class II
Product code
MBF
Recalls
None
Predicates
6

Its longest line of descent runs back 15 generations to K911686 (1991). 148 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 149 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2014: 1 other ancestor2011: 5 other ancestors2009: 2 other ancestors2005: 8 other ancestors2013: 2 other ancestors2010: 3 other ancestors2008: 6 other ancestors2006: 9 other ancestors2012: 4 other ancestors2007: 8 other ancestors2004: 5 other ancestors2003: 8 other ancestors2002: 3 other ancestors2000: 8 other ancestors1998: 7 other ancestors1997: 3 other ancestors2001: 8 other ancestors1999: 6 other ancestors1996: 6 other ancestors1995: 6 other ancestors1994: 3 other ancestors1992: 5 other ancestors1988: 1 other ancestor1987: 5 other ancestors1993: 3 other ancestors1980: 2 other ancestors1991: 2 other ancestors1989: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1981: 1 other ancestorReference device: K100858 · Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies, · Lima-Lto S.P.A. · 2010 · recalledReference device: K101263 · Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies, · Lima-Lto S.P.A. · 2011Reference device: K110598 · SMR Reverse Shoulder System · Lima Corporate S.P.A. · 2011 · recalledReference device: K111212 · SMR Shoulder System- Revision Stems · Lima Corporate S.P.A. · 2011Reference device: K113254 · SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws · Lima Corporate S.P.A. · 2012Reference device: K133349 · SMR TT Metal Back Glenoid · Lima Corporate S.P.A. · 2014Reference device: K113523 · Limacorporate SMR Reverse Shoulder System · Lima Corporate S.P.A. · 2011Reference device: K142139 · SMR 40MM Glenosphere · Lima Corporate S.P.A. · 2014Reference device: K163397 · SMR Hybrid Glenoid System · Lima Corporate S.P.A. · 2017 · recalledReference device: K172456 · Bone Screws 6.5mm · Lima Corporate S.P.A. · 2018 · recalledReference device: K191746 · SMR TT Augmented Glenoid System · Lima Corporate S.P.A. · 2019K911686 · 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) ×2: 2 generations cleared close together, K110599 (2011), K112615 (2011) K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK191963 · SMR Finned Short Stems · Lima Corporate S.P.A. · 201919801990200020102020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 7 other ancestors3 generations back: 16 other ancestors4 generations back: 36 other ancestors5 generations back: 21 other ancestors6 generations back: 16 other ancestors7 generations back: 16 other ancestors8 generations back: 10 other ancestors9 generations back: 5 other ancestors10 generations back: 1 other ancestor K191963 · SMR Finned Short Stems · Lima Corporate S.P.A. · 2019K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK112615 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K080642 · 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 backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  4. 2 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  5. 1 generation backK191963 SMR Finned Short StemsLima Corporate S.P.A. · 2019
  6. This deviceK201905 SMR 140° Reverse Humeral BodyLima Corporate S.P.A. · 2020
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 backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 3 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 2 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. 1 generation backK191963 SMR Finned Short StemsLima Corporate S.P.A. · 2019
  16. This deviceK201905 SMR 140° Reverse Humeral BodyLima Corporate S.P.A. · 2020

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
−4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−2K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
−1K191963SMR Finned Short StemsLima Corporate S.P.A.2019—
0 (this device)K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198110
198610
198750
198810
198910
199120
199250
199330
199430
199560
199660
199730
199870
199960
200080
200180
200230
200380
200450
200580
200690
200780
200860
200920
201030
201150
201240
201320
201410
FIG. 1 — Lineage of K201905, 1991–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MBF device

  1. #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 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? (6)

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
*K191963SMR Finned Short Stems
Summary page 5
…red Humeral extension (K113523), SMR CTA Head Adaptor for Reverse Humeral Body (K131112), Reverse Liners (K110598, K142139) and Humeral stems (K100858, K101263, K111212, K191963). Indications for Use: The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.…
Lima Corporate S.P.A.2019—
*K041066Encore Reverse Shoulder Prosthesis
Summary page 8
…K133349, K113523, K142139, K163397, K172456, K191746. 2 DJO SURGICAL RSP Reverse K041066, K051075, K092873, (LEGALLY ENCORE Shoulder K112069, K141006. MEDICAL, L.P.) P…
Encore Medical L.P.20054
*K051075Encore Reverse Shoulder Prosthesis
Summary page 8
…3349, K113523, K142139, K163397, K172456, K191746. 2 DJO SURGICAL RSP Reverse K041066, K051075, K092873, (LEGALLY ENCORE Shoulder K112069, K141006. MEDICAL, L.P.) Prosthesis…
Encore Medical L.P.20055
*K092873Reverse Shoulder Prosthesis
Summary page 8
…3523, K142139, K163397, K172456, K191746. 2 DJO SURGICAL RSP Reverse K041066, K051075, K092873, (LEGALLY ENCORE Shoulder K112069, K141006. MEDICAL, L.P.) Prosthesis Summary…
Djo Surgical2009—
*K112069RSP Glenoid Baseplate Porous Coated
Summary page 8
…K163397, K172456, K191746. 2 DJO SURGICAL RSP Reverse K041066, K051075, K092873, (LEGALLY ENCORE Shoulder K112069, K141006. MEDICAL, L.P.) Prosthesis Summary of technology comparison: The intended use, design, and materia…
Encore Medical L.P.20111
*K141006RSP Humeral Socket Insert
Summary page 8
…3397, K172456, K191746. 2 DJO SURGICAL RSP Reverse K041066, K051075, K092873, (LEGALLY ENCORE Shoulder K112069, K141006. MEDICAL, L.P.) Prosthesis Summary of technology comparison: The intended use, design, and materials of the…
Djo Global20142
†K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.20102
†K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A.2011—
†K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.20111
†K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.2011—
†K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.2012—
†K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.2014—
†K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.2011—
†K142139SMR 40MM GlenosphereLima Corporate S.P.A.2014—
†K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.20171
†K172456Bone Screws 6.5mmLima Corporate S.P.A.20182
†K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.2019—

Also cleared against K191963: 1 other device →

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

What does this lineage say?

  • The line of descent spans 29 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
  • 42 of the 148 ancestors have a recall of any class; 1 has a Class I recall.
  • 1 other device also cites its predicate K191963.

How does its category compare?

All MBF devices

MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · MBF

2in 2025

2007: 22008: 12009: 12012: 22013: 12014: 12017: 22018: 12019: 22020: 22021: 12022: 42023: 42024: 22025: 22026 (partial year): 1
2007high 4 (2022) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBF

144in 2023

2022: 164 days median2023: 144 days median
2007high 164 (2022) · low 144 (2023)2026

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

Recalls per year · MBF

1in 2023

2009: 12017: 12018: 12019: 22022: 82023: 1
2007high 8 (2022) · low 0 (2007)2026

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

Adverse event reports per year · MBF

255in 2025

2007: 22008: 72009: 162010: 242011: 322012: 302013: 402014: 282015: 492016: 852017: 1932018: 992019: 472020: 242021: 362022: 1142023: 1432024: 1642025: 255
2007high 255 (2025) · low 2 (2007)2025

MAUDE reports naming product code MBF, 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—02
20081—07
20091—116
20100—024
20110—032
20122—030
20131—040
20141—028
20150—049
20160—085
20172—1193
20181—199
20192—247
20202—024
20211—036
202241648114
202341441143
20242—0164
20252—0255
20261—0—

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 (603 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; in case of SMR Short Stems only if sufficient bone stock remains);

• cuff tear arthropathy (CTA Heads only);

• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT 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 SMR TT 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.

A= Anatomic / R=Reverse

*NOTE:

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 TT 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 TT Hybrid Glenoid Reverse Baseplate. The SMR TT Hybrid Glenoid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.

The Dia. 50, 52 and 54mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric). The Dia. 52 and 54mm 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. “K201905: SMR 140° Reverse Humeral Body.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201905

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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