510(k) · Cleared
ClearedDepuy Pinnacle with Gripton Acetabular Cups
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 25, 2007 as substantially equivalent to K001534 (DePuy Orthopaedics, Inc., 2000) and 1 other predicate after a 23-day review. Its family tree reaches back 4 generations to 1993. 72 later devices descend from it.
- Decided
- Jul 25, 2007
- Review
- 23 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930712 (1993). 9 ancestors in all. 72 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 3 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 2 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 1 generation backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- This deviceK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 48 of its ownK090998 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 · cites it directly · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · cites it directly · 20 of its ownK121297 Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 16 of its ownK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K090998Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009 · cites it directly48descendants
- K093646Depuy Pinnacle with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009 · cites it directly31descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · cites it directly21descendants
- K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd. · 2012 · cites it directly20descendants
- K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −3 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −2 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −1 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| +1 | K093646 | Depuy Pinnacle with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| +1 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +1 | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal… | Signature Orthopaedics Pty, Ltd. | 2012 | 2 |
| +2 | K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | 2017 | — |
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 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 10 | 0 |
| 2026 | 8 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K001534 | Pinnacle Acetabular SystemSummary page 2…® with Gription Acetabular Cups have the following similarities to the TM Pinnacle® Acetabular Cups (with Porocoat®) that were cleared in K001534 and K033338: * Identical intended use and indications for use * Identical material * Identical design * Identical sterilization a… | 2000 |
| * | K033338 | Pinnacle Revision SystemSummary page 1…Pinnacle®"Acetabular System, KOO 1534 (June 12, DEVICES: 2000) Pinnacle®~Revision System, K033338 (January 8, 2004) DEVICE DESCRIPTION: The Pinnacle Acetabular System is part of a mo… | 2004 |
What descends from it? (72)
See all 727 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | 2009 | 48 |
| K093646 | Depuy Pinnacle with Gription Acetabular Cups | 2009 | 31 |
| K103721 | Mpact Acetabular System | 2011 | 21 |
| K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series… | 2012 | 20 |
| K221636 | EMPHASYS Acetabular System | 2022 | 7 |
| K243977 | EMPHASYS Acetabular System | 2025 | 1 |
| K140547 | Excera Fitrite Total Hip Arthroplasty System | 2015 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K090998 (DePuy Orthopaedics, Inc., 2009) has gone furthest, with 48 descendants of its own.
- 14 other devices also cite its predicate K001534.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Pinnacle® Acetabular Cups are indicated for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip…
Read the full statement (116 words)
Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Pinnacle® Acetabular Cups are indicated for total hip replacement 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, or total hip replacement.
5. Certain cases of ankylosis.
Porous-coated Pinnacle® Acetabular Cups are indicated for cementless application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071784 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071784: Depuy Pinnacle with Gripton Acetabular Cups.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071784
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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