510(k) · Cleared
ClearedPE-Plus Acetabular Cup
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 Sep 23, 1999 as substantially equivalent to K971705 (Implex Corp., 1997) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1986. 15 later devices descend from it.
- Decided
- Sep 23, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K855231 (1986). 5 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK855231 Howmedica Bipolar ProsthesisHowmedica Corp. · 1986
- 1 generation backK972792 Duration Stabilized Uhmwpe Acetabular ComponentsHowmedica Corp. · 1997
- This deviceK992153 PE-Plus Acetabular CupPlus Orthopedics · 1999
- Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 4 of its ownK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
- Descendant · 2 generations on · 4 of its ownK140975 Mastersl Femoral StemLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 3 of its ownK191374 Revival Modular Hip StemCorin U.S.A. Limited · 2019
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants
- K141327Minima S SystemLima Corporate S.P.A. · 2014 · 2 generations on5descendants
- K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016 · 2 generations on4descendants
- K140975Mastersl Femoral StemLima Corporate S.P.A. · 2014 · 2 generations on4descendants
- K191374Revival Modular Hip StemCorin U.S.A. Limited · 2019 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K855231 | Howmedica Bipolar Prosthesis | Howmedica Corp. | 1986 | — |
| −1 | K972792 | Duration Stabilized Uhmwpe Acetabular Components | Howmedica Corp. | 1997 | — |
| 0 (this device) | K992153 | PE-Plus Acetabular Cup | Plus Orthopedics | 1999 | — |
| +1 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
| +2 | K152903 | REVIVAL (TM) Modular Revision Hip Stem | Corin USA | 2016 | — |
| +2 | K140975 | Mastersl Femoral Stem | Lima Corporate S.P.A. | 2014 | — |
| +2 | K191374 | Revival Modular Hip Stem | Corin U.S.A. Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
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? (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 |
|---|---|---|---|
| * | K971705 | Implex Hep Acetabular Cup System, CementedSummary page 1…Acetabular Cup Cemented Acetabular Cup Prosthesis, hip, semi-constrained, metal/polymer, cemented 21 CFR 888.3350 (87 JDl) implex HEP Acetabular Cup System, Cemented (K971705, 08-06-97), Howmedica Duration Stabilized UHMWPE Exeter All Plastic Acetabular Component (K972792, 10-16-97) The PE-PLUS Acetabu… | 1997 |
| * | K972792 | Duration Stabilized Uhmwpe Acetabular ComponentsSummary page 1…d 21 CFR 888.3350 (87 JDl) implex HEP Acetabular Cup System, Cemented (K971705, 08-06-97), Howmedica Duration Stabilized UHMWPE Exeter All Plastic Acetabular Component (K972792, 10-16-97) The PE-PLUS Acetabular Cup is made of an ultra high molecular weight polyethylene (ASTM F 648) and accommodates three… | 1997 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K112158 (Lima Corporate S.P.A., 2012) has gone furthest, with 13 descendants of its own.
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 PE-PLUS Acetabular Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs restructuring.
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/K992153 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992153: PE-Plus Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992153
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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