510(k) Report

510(k) · Cleared

Cleared

SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral Heads

K112900510(k) TraditionalCleared Jun 1, 2012242-day reviewClass II21 CFR 888.3690

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. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Jun 1, 2012 as substantially equivalent to K010657 (Biomet Manufacturing, Inc., 2001) and 5 other predicates after a 242-day review. Its family tree reaches back 7 generations to 1980.

Decided
Jun 1, 2012
Review
242 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
6

Its longest line of descent runs back 7 generations to K800494 (1980). 29 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors1999: 4 other ancestors1998: 2 other ancestors2008: 1 other ancestor2003: 1 other ancestor2000: 2 other ancestors1991: 3 other ancestors2006: 1 other ancestor1994: 1 other ancestor1992: 2 other ancestors1987: 1 other ancestor1980: 1 other ancestor1995: 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 · recalledK800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980K991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK010827 · Copeland MB/HA Resurfacing Humeral Heads · Biomet Orthopedics, Inc. · 2001 · recalledK031971 · Global Cap Resurfacing Replacement Shoulder · DePuy Orthopaedics, Inc. · 2003K051843 · Copeland Eas Humeral Resurfacing Heads · Biomet, Inc. · 2005 · recalledK080990 · Depuy Global C.AP. Cta Resurfacing Shoulder · DePuy Orthopaedics, Inc. · 20081980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 9 other ancestors4 generations back: 4 other ancestors5 generations back: 1 other ancestor K080990 · Depuy Global C.AP. Cta Resurfacing Shoulder · DePuy Orthopaedics, Inc. · 2008K051843 · Copeland Eas Humeral Resurfacing Heads · Biomet, Inc. · 2005 · recalledK031971 · Global Cap Resurfacing Replacement Shoulder · DePuy Orthopaedics, Inc. · 2003K010827 · Copeland MB/HA Resurfacing Humeral Heads · Biomet Orthopedics, Inc. · 2001 · recalledK002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980−50
  1. Root · 7 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
  2. 6 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
  3. 5 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
  4. 4 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
  5. 3 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
  6. 2 generations backK051843 Copeland Eas Humeral Resurfacing HeadsBiomet, Inc. · 2005 · Recalled
  7. 1 generation backK080990 Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc. · 2008
  8. This deviceK112900 SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K800494New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc.1980—
−6K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999—
−5K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20001
−4K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc.20011
−3K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc.2003—
−2K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.20051
−1K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.2008—
0 (this device)K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198710
199130
199220
199410
199510
199820
199940
200020
200120
200310
200610
200810
FIG. 1 — Lineage of K112900, 1980–2012Source: 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.

Planning a device in HSD? 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 HSD device

  1. #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (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
*K010657Copeland MB Resurfacing Humeral Heads
Summary page 2
…. The glenoid components, used in total shoulder replacement, are intended for cemented use only. Predicate Devices: " Copeland MB Resurfacing Humneral Heads (Biomet, K0 10657); * Copeland LAS Humeral Resurfacing Heads (Biomet, KO051843); * Global CAP Resurfacing Replacement Shoulder(DePuy Orthopaedics,…
Biomet Manufacturing, Inc.2001—
*K051843Copeland Eas Humeral Resurfacing Heads
Summary page 2
…re intended for cemented use only. Predicate Devices: " Copeland MB Resurfacing Humneral Heads (Biomet, K0 10657); * Copeland LAS Humeral Resurfacing Heads (Biomet, KO051843); * Global CAP Resurfacing Replacement Shoulder(DePuy Orthopaedics, K03 1971); * Global CAP CTA Resurfacing Shoulder (DePuy Ortho…
Biomet, Inc.20051
*K031971Global Cap Resurfacing Replacement Shoulder
Summary page 2
…rfacing Humneral Heads (Biomet, K0 10657); * Copeland LAS Humeral Resurfacing Heads (Biomet, KO051843); * Global CAP Resurfacing Replacement Shoulder(DePuy Orthopaedics, K03 1971); * Global CAP CTA Resurfacing Shoulder (DePuy Orthopaedics, K080990); * Bio-Modular shoulder system (Biomet, K9921 19); * DePuy…
DePuy Orthopaedics, Inc.2003—
*K080990Depuy Global C.AP. Cta Resurfacing Shoulder
Summary page 2
…rfacing Heads (Biomet, KO051843); * Global CAP Resurfacing Replacement Shoulder(DePuy Orthopaedics, K03 1971); * Global CAP CTA Resurfacing Shoulder (DePuy Orthopaedics, K080990); * Bio-Modular shoulder system (Biomet, K9921 19); * DePuy Global Shoulder Glenoid (DePuy K98 1487). Comn~arable Features to P…
DePuy Orthopaedics, Inc.2008—
*K992119Bio-Modular Shoulder System
Summary page 2
…surfacing Replacement Shoulder(DePuy Orthopaedics, K03 1971); * Global CAP CTA Resurfacing Shoulder (DePuy Orthopaedics, K080990); * Bio-Modular shoulder system (Biomet, K9921 19); * DePuy Global Shoulder Glenoid (DePuy K98 1487). Comn~arable Features to Predicate Devices: The intended use and indication…
Biomet, Inc.19991
*K981487Depuy Global Shoulder Glenoid
Summary page 2
…K03 1971); * Global CAP CTA Resurfacing Shoulder (DePuy Orthopaedics, K080990); * Bio-Modular shoulder system (Biomet, K9921 19); * DePuy Global Shoulder Glenoid (DePuy K98 1487). Comn~arable Features to Predicate Devices: The intended use and indications for the Limacorporate SMR Resurfacing Shoulder S…
DePuy Orthopaedics, Inc.1998—
†K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.20102

Also cleared against K010657: 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 32 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
  • 6 of the 29 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K010657.

How does its category compare?

All HSD devices

HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · HSD

1in 2024

2007: 42008: 32011: 22012: 22013: 42014: 12016: 32018: 12020: 22022: 12024: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007: 72 days median2008: 92 days median2013: 218 days median2016: 145 days median
2007high 218 (2013) · low 72 (2007)2026

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

Recalls per year · HSD

1in 2020

2008: 22009: 22017: 32018: 12020: 1
2007high 3 (2017) · low 0 (2007)2026

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

Adverse event reports per year · HSD

757in 2025

2007: 1282008: 2592009: 1562010: 2252011: 2412012: 2542013: 2882014: 4342015: 5742016: 7842017: 9852018: 6492019: 8302020: 6582021: 5732022: 5082023: 5862024: 6932025: 757
2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, 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
20074720128
20083922259
20090—2156
20100—0225
20112—0241
20122—0254
201342180288
20141—0434
20150—0574
201631450784
20170—3985
20181—1649
20190—0830
20202—1658
20210—0573
20221—0508
20230—0586
20241—0693
20250—0757
20260—0—

What is it indicated for?

The SMR Resurfacing Shoulder Prosthesis system is indicated for partial or total primary shoulder replacement in patients where the humeral head and neck have sufficient bone stock to support the prosthesis. The Standard Resurfacing heads are indicated for partial or total shoulder replacement when the rotator cuff is intact or reconstructable. Specific indications include: * non-inflammatory degenerative joint disease including osteoarthritis and…

Read the full statement (120 words)

The SMR Resurfacing Shoulder Prosthesis system is indicated for partial or total primary shoulder replacement in patients where the humeral head and neck have sufficient bone stock to support the prosthesis.

The Standard Resurfacing heads are indicated for partial or total shoulder replacement when the rotator cuff is intact or reconstructable. Specific indications include:

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

* Post-traumatic osteoarthritis;

* Rheumatoid arthritis.

The CTA Resurfacing Heads are indicated for partial shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

*Rotator cuff tear arthropathy.

The humeral heads and stems are intended for uncemented use only. The glenoid components, used in total shoulder replacement, are intended for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K010657

4 other devices cite the same predicate.

  • K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc. · 2013
  • K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC · 2013
  • K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006
  • K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc. · 20051 recall

More from Lima Corporate S.P.A.

64 FDA decisions under this applicant name. See the company

  • K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A. · 2026
  • K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A. · 2025
  • K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
  • K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A. · 2025
  • K243615Physica Porous Femoral ComponentsLima Corporate S.P.A. · 2024

Recent decisions in HSD

The HSD category page

  • K233260Univers Revers CA Head and AdapterArthrex, Inc. · 2024
  • K221232Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
  • K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

https://510kreport.com/device/K112900 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112900: SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112900

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