510(k) · Cleared
ClearedPROFEMUR® GLADIATOR® Cemented Classic Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Dec 10, 2020 as substantially equivalent to K111910 (Wrightmedicaltechnologyinc, 2011) and 2 other predicates after a 185-day review. Its family tree reaches back 7 generations to 1994. 2 of the 28 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Dec 10, 2020
- Review
- 185 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K935452 (1994). 26 ancestors in all, the oldest K851422 (1985). 1 later device descends from it, 1 citing it directly. 2 of the 28 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 backK111910 Gladiator Hip StemWrightmedicaltechnologyinc · 2011
- This deviceK201519 PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK213816 MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K213816MPO Hip InstrumentsMicroport Orthopedics, Inc. · 2022 · 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 | K111910 | Gladiator Hip Stem | Wrightmedicaltechnologyinc | 2011 | — |
| 0 (this device) | K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | Microport Orthopedics, Inc. | 2020 | — |
| +1 | K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022 | — |
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 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K111910 | Gladiator Hip StemSummary page 4…ode: Orthopedics/87 Product Codes: JDI, KWL, KWY, LZO Predicate Device: PROFEMUR® GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) Reference Device: PROFEMUR® Cobalt Chrome Modular Necks (K091423, SE… | 2011 |
| * | K091423 | Profemur Hip System Modular NecksSummary page 4…GLADIATOR® Cemented Stem (K111910, SE 10/14/2011) Reference Device: PROFEMUR® Cobalt Chrome Modular Necks (K091423, SE 08/25/2009; K100866, SE 04/28/2010) PROFEMUR® GLADIATOR® Thin HA Cl… | 2009 |
| * | K100866 | Profemur Hip System Modular NecksSummary page 4…SE 10/14/2011) Reference Device: PROFEMUR® Cobalt Chrome Modular Necks (K091423, SE 08/25/2009; K100866, SE 04/28/2010) PROFEMUR® GLADIATOR® Thin HA Classic Stem w/ Collar (K2… | 2010 |
| † | K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | 2020 |
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 |
|---|---|---|---|
| K213816 | MPO Hip Instruments | 2022 | 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.
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.
- 7 of the 26 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K213816 (Microport Orthopedics, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K111910.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
PROFEMUR® GLADIATOR® Cemented Classic Stems 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
PROFEMUR® GLADIATOR® Cemented Classic Stems are single use implants intended for cemented arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201519: PROFEMUR® GLADIATOR® Cemented Classic Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201519
Report an extraction error
Are you the manufacturer?
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