510(k) · Cleared
ClearedRevival Modular Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin U.S.A. Limited · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 22, 2019 as substantially equivalent to K152903 (Corin USA, 2016) and 1 other predicate after a 60-day review. Its family tree reaches back 9 generations to 1994. 1 of the 74 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jul 22, 2019
- Review
- 60 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K921308 (1994). 70 ancestors in all, the oldest K850055 (1985). 3 later devices descend from it, 1 citing it directly. 1 of the 74 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 5 generations between
- 3 generations backK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- 2 generations backK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- 1 generation backK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
- This deviceK191374 Revival Modular Hip StemCorin U.S.A. Limited · 2019
- Descendant · cites it directly · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- Descendant · 3 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 8 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 7 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 6 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 5 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 4 generations backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- 3 generations backK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- 2 generations backK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- 1 generation backK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
- This deviceK191374 Revival Modular Hip StemCorin U.S.A. Limited · 2019
Class I recalls in this family
- K091423 Profemur Hip System Modular Necks2 generations back · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −8 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −7 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −6 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −5 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −4 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| −3 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| −2 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| −1 | K152903 | REVIVAL (TM) Modular Revision Hip Stem | Corin USA | 2016 | — |
| 0 (this device) | K191374 | Revival Modular Hip Stem | Corin U.S.A. Limited | 2019 | — |
| +1 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +2 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +3 | K261576 | Icona Hip Stem | Corin, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 9 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 8 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152903 | REVIVAL (TM) Modular Revision Hip StemSummary page 4…emi-constrained cemented or nonporous uncemented prosthesis Legally Marketed Devices to which Substantial Equivalence is claimed: e Revival™ Modular Revision Hip Stem (K152903) e Lima MODULUS stem (K112158) 10. Device Description: The Revival™ Modular Hip Stem is a modular stem manufactured from titani… | 2016 |
| * | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsSummary page 4…nporous uncemented prosthesis Legally Marketed Devices to which Substantial Equivalence is claimed: e Revival™ Modular Revision Hip Stem (K152903) e Lima MODULUS stem (K112158) 10. Device Description: The Revival™ Modular Hip Stem is a modular stem manufactured from titanium alloy (Ti6Al4V ELI) with a… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell… | 2021 | 2 |
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.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 8 companies; a new generation was cleared every 3.2 years on median.
- 23 of the 70 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201657 (Corin, Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K152903.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The Revival™ Modular Hip Stem is indicated in revision surgery of femoral components, following failure of a primary cemented or un-cemented prosthesis. The Revival™ Modular Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival™ Modular Hip Stem include: Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis and hip dysplasia Aseptic necrosis of the femoral…
Read the full statement (103 words)
The Revival™ Modular Hip Stem is indicated in revision surgery of femoral components, following failure of a primary cemented or un-cemented prosthesis. The Revival™ Modular Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty.
The indications for the Revival™ Modular Hip Stem include:
Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis and hip dysplasia
Aseptic necrosis of the femoral head
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union and femoral neck fractures
Treatment of traumatic dislocations of the hip
Failures of osteotomy
Treatment of arthrodesis
The Revival™ Modular Hip Stem is indicated for cementless, single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191374: Revival Modular Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191374
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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