510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

TEMA Elbow System

K181362510(k) TraditionalCleared Feb 16, 2019269-day reviewClass II21 CFR 888.3150Recalls 1

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. · JDC Prosthesis, Elbow, Constrained, Cemented

Cleared on Feb 16, 2019 as substantially equivalent to K001989 (Zimmer, Inc., 2000) and 8 other predicates after a 269-day review. Its family tree reaches back 6 generations to 1989. 1 later device descends from it. It has been recalled once.

Decided
Feb 16, 2019
Review
269 days
Class
Class II
Product code
JDC
Recalls
1
Predicates
9

Its longest line of descent runs back 6 generations to K883665 (1989). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2009: 1 other ancestor2005: 3 other ancestors2001: 3 other ancestors2000: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor2022: 1 descendant clearedReference device: K100858 · Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies, · Lima-Lto S.P.A. · 2010 · recalledReference device: K133349 · SMR TT Metal Back Glenoid · Lima Corporate S.P.A. · 2014K883665 · Coonrad Iii Total Elbow · Zimmer, Inc. · 1989K973357 · Coonrad/Morrey Total Elbow, New Hinge Pin · Zimmer, Inc. · 1998 · recalledK031218 · Modification to Tornier Total Elbow Prosthesis · Tornier · 2003K070787 · Latitude Elbow Prothesis · Tornier · 2007K100562 · Latitude Elbow Prosthesis · Tornier, Inc. · 2010 · recalledK171010 · Latitude EV Total Elbow Arthroplasty · Tornier, Inc. · 20171990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant K171010 · Latitude EV Total Elbow Arthroplasty · Tornier, Inc. · 2017K100562 · Latitude Elbow Prosthesis · Tornier, Inc. · 2010 · recalledK070787 · Latitude Elbow Prothesis · Tornier · 2007K031218 · Modification to Tornier Total Elbow Prosthesis · Tornier · 2003K973357 · Coonrad/Morrey Total Elbow, New Hinge Pin · Zimmer, Inc. · 1998 · recalledK883665 · Coonrad Iii Total Elbow · Zimmer, Inc. · 1989−50
  1. Root · 6 generations backK883665 Coonrad Iii Total ElbowZimmer, Inc. · 1989
  2. 5 generations backK973357 Coonrad/Morrey Total Elbow, New Hinge PinZimmer, Inc. · 1998 · Recalled
  3. 4 generations backK031218 Modification to Tornier Total Elbow ProsthesisTornier · 2003
  4. 3 generations backK070787 Latitude Elbow ProthesisTornier · 2007
  5. 2 generations backK100562 Latitude Elbow ProsthesisTornier, Inc. · 2010 · Recalled
  6. 1 generation backK171010 Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
  7. This deviceK181362 TEMA Elbow SystemLima Corporate S.P.A. · 2019
  8. Descendant · cites it directly · 0 of its ownK222807 TEMA Elbow system - Line extensionLima Corporate S.P.A. · 2022 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K222807TEMA Elbow system - Line extensionLima Corporate S.P.A. · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K883665Coonrad Iii Total ElbowZimmer, Inc.1989—
−5K973357Coonrad/Morrey Total Elbow, New Hinge PinZimmer, Inc.19981
−4K031218Modification to Tornier Total Elbow ProsthesisTornier2003—
−3K070787Latitude Elbow ProthesisTornier2007—
−2K100562Latitude Elbow ProsthesisTornier, Inc.20102
−1K171010Latitude EV Total Elbow ArthroplastyTornier, Inc.2017—
0 (this device)K181362TEMA Elbow SystemLima Corporate S.P.A.2019—
+1K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.20221

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200020
200130
200530
200910
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K181362, 1989–2022Source: 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 JDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (9)

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
*K001989Coonrad/Morrey Total Elbow. Model 32-8105 Series
Summary page 5
…ative manual testing is performed. Predicate Devices: The following predicate devices for Limacorporate TEMA Elbow System: • Conrad Morrey Total Elbow (Zimmer Inc., K001989 / K053189); • Latitude Elbow Prosthesis (Tornier Inc., K100562 / K171010); • Solar Elbow Prosthesis (Howmedica Osteonics Co…
Zimmer, Inc.200010
*K053189Coonrad/Morrey Total Elbow, Model 8105 Series
Summary page 5
…al testing is performed. Predicate Devices: The following predicate devices for Limacorporate TEMA Elbow System: • Conrad Morrey Total Elbow (Zimmer Inc., K001989 / K053189); • Latitude Elbow Prosthesis (Tornier Inc., K100562 / K171010); • Solar Elbow Prosthesis (Howmedica Osteonics Corp aka Str…
Zimmer, Inc.20052
*K100562Latitude Elbow Prosthesis
Summary page 5
…ing predicate devices for Limacorporate TEMA Elbow System: • Conrad Morrey Total Elbow (Zimmer Inc., K001989 / K053189); • Latitude Elbow Prosthesis (Tornier Inc., K100562 / K171010); • Solar Elbow Prosthesis (Howmedica Osteonics Corp aka Stryker Corporation, K980502); • Discovery Elbow…
Tornier, Inc.20102
*K171010Latitude EV Total Elbow Arthroplasty
Summary page 5
…ate devices for Limacorporate TEMA Elbow System: • Conrad Morrey Total Elbow (Zimmer Inc., K001989 / K053189); • Latitude Elbow Prosthesis (Tornier Inc., K100562 / K171010); • Solar Elbow Prosthesis (Howmedica Osteonics Corp aka Stryker Corporation, K980502); • Discovery Elbow (Biomet In…
Tornier, Inc.2017—
*K980502Osteonics Total Elbow System
Summary page 5
…01989 / K053189); • Latitude Elbow Prosthesis (Tornier Inc., K100562 / K171010); • Solar Elbow Prosthesis (Howmedica Osteonics Corp aka Stryker Corporation, K980502); • Discovery Elbow (Biomet Inc., K013042 / K051975 / K090473); • Nexel Total Elbow (Zimmer Inc., K123862). Reference Devi…
Osteonics Corp.19981
*K013042Discovery Elbow
Summary page 5
…sis (Tornier Inc., K100562 / K171010); • Solar Elbow Prosthesis (Howmedica Osteonics Corp aka Stryker Corporation, K980502); • Discovery Elbow (Biomet Inc., K013042 / K051975 / K090473); • Nexel Total Elbow (Zimmer Inc., K123862). Reference Devices: • K100858 – SMR Shoulder System…
Biomet Orthopedics, Inc.20013
*K051975Porous Coated Discovery Elbow
Summary page 5
…er Inc., K100562 / K171010); • Solar Elbow Prosthesis (Howmedica Osteonics Corp aka Stryker Corporation, K980502); • Discovery Elbow (Biomet Inc., K013042 / K051975 / K090473); • Nexel Total Elbow (Zimmer Inc., K123862). Reference Devices: • K100858 – SMR Shoulder System • K1333…
Biomet, Inc.20052
*K090473Discovery Elbow - X-Small
Summary page 5
…100562 / K171010); • Solar Elbow Prosthesis (Howmedica Osteonics Corp aka Stryker Corporation, K980502); • Discovery Elbow (Biomet Inc., K013042 / K051975 / K090473); • Nexel Total Elbow (Zimmer Inc., K123862). Reference Devices: • K100858 – SMR Shoulder System • K133349 – SMR T…
Biomet Manufacturing Corp2009—
*K123862Zimmer Nexel Total Elbow
Summary page 5
…(Howmedica Osteonics Corp aka Stryker Corporation, K980502); • Discovery Elbow (Biomet Inc., K013042 / K051975 / K090473); • Nexel Total Elbow (Zimmer Inc., K123862). Reference Devices: • K100858 – SMR Shoulder System • K133349 – SMR TT Metal Back Glenoid Technological Characteris…
Zimmer, Inc.2013—
†K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.20102
†K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.2014—

Also cleared against K001989: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.20220

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 25, 2023Class IIZ-1261-2023Employee errorDue to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
  • 7 of the 18 ancestors have a recall of any class.
  • Of its descendants, K222807 (Lima Corporate S.P.A., 2022) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K001989.

How does its category compare?

All JDC devices

JDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · JDC

2in 2019

2009: 12013: 12015: 12016: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDC

Too few JDC 510(k)s in any year since 2007 to give a median.

Recalls per year · JDC

2in 2019

2008: 22009: 62011: 22012: 22019: 22026 (partial year): 1
2007high 6 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JDC

212in 2025

2007: 332008: 472009: 452010: 862011: 622012: 792013: 742014: 792015: 2392016: 1762017: 4012018: 2482019: 1902020: 1792021: 1572022: 1292023: 1892024: 1752025: 212
2007high 401 (2017) · low 33 (2007)2025

MAUDE reports naming product code JDC, 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
20070—033
20080—247
20091—645
20100—086
20110—262
20120—279
20131—074
20140—079
20151—0239
20161—0176
20170—0401
20180—0248
20192—2190
20200—0179
20210—0157
20220—0129
20230—0189
20240—0175
20250—0212
20260—1—

What is it indicated for?

TEMA Elbow System is intended for use in cemented applications for patients suffering from disability due to: 1. Elbow joint destruction which significantly compromises the activities of daily living 2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia. 3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain 4. Revision where other devices or treatments have failed. 5.…

Read the full statement (135 words)

TEMA Elbow System is intended for use in cemented applications for patients suffering from disability due to:

1. Elbow joint destruction which significantly compromises the activities of daily living

2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.

3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain

4. Revision where other devices or treatments have failed.

5. Correction of severe functional deformity.

6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.

7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

The unlinked, semi-constrained version is intended for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

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

Also cleared against K001989

3 other devices cite the same predicate.

  • K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019
  • K123862Zimmer Nexel Total ElbowZimmer, Inc. · 2013
  • K053189Coonrad/Morrey Total Elbow, Model 8105 SeriesZimmer, Inc. · 20052 recalls

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 JDC

The JDC category page

  • K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019
  • K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016
  • K150501Zimmer Nexel Total Elbow Ulnar Cement DiverterZimmer, Inc. · 2015
  • K123862Zimmer Nexel Total ElbowZimmer, Inc. · 2013
  • K090473Discovery Elbow - X-SmallBiomet Manufacturing Corp · 2009

https://510kreport.com/device/K181362 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181362: TEMA Elbow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181362

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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