510(k) · Cleared
ClearedPROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 25, 2020 as substantially equivalent to K112150 (Wrightmedicaltechnologyinc, 2011) after a 114-day review. Its family tree reaches back 7 generations to 1994. 2 of the 26 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Apr 25, 2020
- Review
- 114 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K935452 (1994). 24 ancestors in all, the oldest K851422 (1985). 1 later device descends from it, 1 citing it directly. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 6 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 5 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 4 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 2 generations backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- 1 generation backK112150 Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011
- This deviceK200007 PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK250444 NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K250444NEXUS® Hip StemMicroport Orthopedics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −6 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −5 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −4 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| −1 | K112150 | Profemur Gladiator HA Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
| 0 (this device) | K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | Microport Orthopedics, Inc. | 2020 | — |
| +1 | K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
| 2010 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
2 devices in this family have 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? (1)
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 |
|---|---|---|---|
| * | K112150 | Profemur Gladiator HA Hip StemSummary page 4…Class II Panel Code: Orthopedic/87 Product Code: LZO, LPH Predicate Device: K112150 PROFEMUR® GLADIATOR® HA Hip Stem Reference Device: K110399 P… | 2011 |
| † | K110399 | Gladiator Plasma Classic Hip Stem | 2011 |
| † | K191632 | PROFEMUR TL2 Stems | 2019 |
| † | K190123 | MicroPort CoCr Femoral Heads | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250444 | NEXUS® Hip Stem | 2025 | 0 |
Has anything in its family been recalled? (2 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.
- K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- 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 26 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 24 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K250444 (Microport Orthopedics, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112150.
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. 2020, 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?
PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are intended for use in total hip arthroplasty for
reduction or relief of pain and/or improved hip function in skeletally mature patients.
1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli,
and painful hip dysplasia;
2) inflammatory degenerative joint disease such as rheumatoid arthritis;
3) correction of functional deformity; and,
4) revision procedures where other treatments or devices have failed
Hydroxyapatite coatings applied to implant surfaces are intended for uncemented arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200007: PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200007
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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