510(k) · Cleared
ClearedPlus Orthopedics Cemented Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jun 6, 2003 as substantially equivalent to K922561 (U.S. Medical Products, Inc., 1993) and 3 other predicates after a 53-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Jun 6, 2003
- Review
- 53 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K952191 (1995). 9 ancestors in all, the oldest K900638 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK952191 Forged Cemented StemEncore Orthopedics, Inc. · 1995
- 2 generations backK961890 Foundation 9MM Forged Cemented StemEncore Orthopedics, Inc. · 1996 · Recalled
- 1 generation backK991227 8MM Forged Cemented StemEncore Orthopedics, Inc. · 1999
- This deviceK031165 Plus Orthopedics Cemented Hip StemPlus Orthopedics · 2003
- Descendant · cites it directly · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952191 | Forged Cemented Stem | Encore Orthopedics, Inc. | 1995 | — |
| −2 | K961890 | Foundation 9MM Forged Cemented Stem | Encore Orthopedics, Inc. | 1996 | 1 |
| −1 | K991227 | 8MM Forged Cemented Stem | Encore Orthopedics, Inc. | 1999 | — |
| 0 (this device) | K031165 | Plus Orthopedics Cemented Hip Stem | Plus Orthopedics | 2003 | — |
| +1 | K123598 | Smith & Nephew, Inc. Hip System Instrumentation | Smith & Nephew, Inc. | 2013 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (4)
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 |
|---|---|---|---|
| * | K922561 | Consensus (TM) Total Hip SystemSummary page 1…er, Cemented (per 21 CFR section 888.3350) Ea uivaient Device This cemented hip stem is equivalent iR design, materials, strength and indications tu the Consensus Stem (K922561 - Hayes Medical), the Foundation Hip (IC991227 - Encore Orthopedics), the Synergy stem (K990369 Smith & -… | 1993 |
| * | K991227 | 8MM Forged Cemented StemSummary page 1…ivaient Device This cemented hip stem is equivalent iR design, materials, strength and indications tu the Consensus Stem (K922561 - Hayes Medical), the Foundation Hip (IC991227 - Encore Orthopedics), the Synergy stem (K990369 Smith & - - Nephew) and the Summit s… | 1999 |
| * | K990369 | Synergy Cemented Hip StemSummary page 1…ent iR design, materials, strength and indications tu the Consensus Stem (K922561 - Hayes Medical), the Foundation Hip (IC991227 - Encore Orthopedics), the Synergy stem (K990369 Smith & - - Nephew) and the Summit stem (KO13352 J&J/DePuy). Device Description This… | 1999 |
| * | K013352 | Summit Cemented Hip Prosthesis | 2001 |
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 |
|---|---|---|---|
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K123598 (Smith & Nephew, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K922561.
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.
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 PLUS Orthopedics Cemented Hip Stern is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously faiIed hip arthropIasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031165: Plus Orthopedics Cemented 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/K031165
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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