510(k) · Cleared
ClearedDepuy Pinnacle 100 with Gription Acetabular Cups
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jun 12, 2009 as substantially equivalent to K071784 (DePuy Orthopaedics, Inc., 2007) and 1 other predicate after a 65-day review. Its family tree reaches back 5 generations to 1993. 48 later devices descend from it.
- Decided
- Jun 12, 2009
- Review
- 65 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930712 (1993). 10 ancestors in all. 48 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 4 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 2 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 1 generation backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- This deviceK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- Descendant · cites it directly · 31 of its ownK093646 Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- Descendant · 2 generations on · 20 of its ownK121297 Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 2012 · Recalled
- Descendant · cites it directly · 16 of its ownK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK171181 PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK221636 EMPHASYS Acetabular SystemDepuy Ireland UC · 2022
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K093646Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009 · cites it directly31descendants
- K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd. · 2012 · 2 generations on20descendants
- K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017 · cites it directly16descendants
- K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017 · 2 generations on10descendants
- K221636EMPHASYS Acetabular SystemDepuy Ireland UC · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −4 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −2 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| 0 (this device) | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| +1 | K093646 | Depuy Pinnacle with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| +2 | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal… | Signature Orthopaedics Pty, Ltd. | 2012 | 2 |
| +1 | K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | 2017 | — |
| +2 | K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | Microport Orthopedics, Inc. | 2017 | — |
| +2 | K221636 | EMPHASYS Acetabular System | Depuy Ireland UC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K071784 | Depuy Pinnacle with Gripton Acetabular CupsSummary page 1…KWA, JDI, LZO and LPH SUBSTANTIALLY EQUIVALENT Pinnacle with Gription Acetabular Cups, DEVICES: K071784 (July 25, 2007) Pinnacle Acetabular System (Porocoat),… | 2007 |
| * | K001534 | Pinnacle Acetabular SystemSummary page 1…K071784 (July 25, 2007) Pinnacle Acetabular System (Porocoat), K001534 (June 12, 2000) DePuy Orthopaedics, Inc. K090998: Additional Information Page 6 of 25… | 2000 |
What descends from it? (48)
See all 484 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 16 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K093646 (DePuy Orthopaedics, Inc., 2009) has gone furthest, with 31 descendants of its own.
- 6 other devices also cite its predicate K071784.
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. 2009, 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 Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip…
Read the full statement (98 words)
The Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement.
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
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 replacement arthroplasty, of total hip replacement.
5. Certain cases of ankylosis.
Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090998: Depuy Pinnacle 100 with Gription Acetabular Cups.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090998
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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