510(k) · Cleared
Recalled · 2011Escalade Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 16, 2011 as substantially equivalent to K042565 (Ortho Development Corp., 2005) and 2 other predicates after a 118-day review. Its family tree reaches back 4 generations to 1993. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 16, 2011
- Review
- 118 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K930712 (1993). 11 ancestors in all. 3 later devices descend from it, 2 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 backK062148 Depuy Pinnacle Altrx Acetabular Cup LinerDePuy Orthopaedics, Inc. · 2006
- This deviceK103384 Escalade Acetabular Cup SystemOrtho Development · 2011
- Descendant · cites it directly · 1 of its ownK161080 Escalade Legend Acetabular ShellOrtho Development Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK242833 Legend® Acetabular ShellOrtho Development Corp. · 2024
- Descendant · cites it directly · 0 of its ownK183532 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K161080Escalade Legend Acetabular ShellOrtho Development Corporation · 2016 · cites it directly1descendant
- K242833Legend® Acetabular ShellOrtho Development Corp. · 2024 · 2 generations on0descendants
- K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019 · cites it directly0descendants
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 | K062148 | Depuy Pinnacle Altrx Acetabular Cup Liner | DePuy Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K103384 | Escalade Acetabular Cup System | Ortho Development | 2011 | — |
| +1 | K161080 | Escalade Legend Acetabular Shell | Ortho Development Corporation | 2016 | — |
| +2 | K242833 | Legend® Acetabular Shell | Ortho Development Corp. | 2024 | — |
| +1 | K183532 | Latitud Hip Replacement System | Meril Healthcare Pvt., Ltd. | 2019 | — |
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 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 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? (3)
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 |
|---|---|---|---|
| * | K042565 | Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus DCM LinerSummary page 1…CE PRODUCT CODE: [PH, [ZO PREDICATE DEVICES: TniPlus Acetabular Cup System, Ortho Development Corp; (K042565) Pinnacle Acetabular Cup System, DePuy Orthopedics, Inc.… | 2005 |
| * | K062148 | Depuy Pinnacle Altrx Acetabular Cup LinerSummary page 1…(K042565) Pinnacle Acetabular Cup System, DePuy Orthopedics, Inc. (K062148, K000306) DEVICE DESCRIPTIONS: The Escalade Acetabular Cup System is a modular system intended for the replacement of the natur… | 2006 |
| * | K000306 | Pinnacle Acetabular SystemSummary page 1…(K042565) Pinnacle Acetabular Cup System, DePuy Orthopedics, Inc. (K062148, K000306) DEVICE DESCRIPTIONS: The Escalade Acetabular Cup System is a modular system intended for the replacement of the natural articu… | 2000 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2011 | Not classified | Z-0740-2012 | Device Design | Tip of hex-head screwdriver may break off during use in hip replacement procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K161080 (Ortho Development Corporation, 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K042565.
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. 2011, 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?
The Escalade Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Escalade Acetabular Cup System is compatible with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem). Total hip arthroplasty is indicated for…
Read the full statement (122 words)
The Escalade Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Escalade Acetabular Cup System is compatible with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem).
Total hip arthroplasty is indicated for the following conditions:
1. Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Fractures of the femoral neck or head.
4. Avascular necrosis of the femoral head.
5. Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103384: Escalade Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103384
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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