510(k) · Cleared
ClearedConformity stem, cemented
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corporation · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jan 3, 2020 as substantially equivalent to K152530 (United Orthopedic Corporation, 2016) after a 259-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Jan 3, 2020
- Review
- 259 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K935452 (1994). 29 ancestors in all, the oldest K802627 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 7 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 6 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 5 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 4 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 3 generations backK042959 Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004
- 2 generations backK082239 Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008
- 1 generation backK152530 UCP StemUnited Orthopedic Corporation · 2016
- This deviceK191056 Conformity stem, cementedUnited Orthopedic Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −7 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −6 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −5 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −4 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K042959 | Depuy C-Stem Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2004 | — |
| −2 | K082239 | Depuy C-Stem Amt | DePuy Orthopaedics, Inc. | 2008 | — |
| −1 | K152530 | UCP Stem | United Orthopedic Corporation | 2016 | — |
| 0 (this device) | K191056 | Conformity stem, cemented | United Orthopedic Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 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.
Planning a device in JDI? 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? (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 |
|---|---|---|---|
| * | K152530 | UCP StemSummary page 4…1 CFR 888.3350) Device Class Class II Classification Panel Orthopedics Product Code JDI, LZO, KWY Predicate Device “United” UCP stem (K152530) Reference Device “United” U2 Hip Stem (K003237) UOC-FDA-053… | 2016 |
| † | K003237 | U2 Hip Stem, TI Porous Coated | 2001 |
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 26 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 29 ancestors have a recall of any class.
- 1 other device also cites its predicate K152530.
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?
The device is indicated for use in hip arthroplasty in skeletally mature patients with the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dyplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacment or total hip replacement.
5. Certain cases of ankylosis.
Conformity stem, cemented is for cemented 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/K191056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191056: Conformity stem, cemented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191056
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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