510(k) Report

510(k) · Cleared

Cleared

Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and Flared)

K072888510(k) SpecialCleared Jan 10, 200892-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Encore Medical L.P. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 10, 2008 as substantially equivalent to K974093 (Encore Orthopedics, Inc., 1998) and 2 other predicates after a 92-day review. Its family tree reaches back 1 generation to 1998. 103 later devices descend from it.

Decided
Jan 10, 2008
Review
92 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K974093 (1998). 3 ancestors in all. 103 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors2019: 7 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2015: 3 descendants cleared2014: 6 descendants cleared2016: 3 descendants cleared2018: 4 descendants cleared2021: 10 descendants cleared2022: 12 descendants cleared2017: 6 descendants cleared2013: 1 descendant cleared2020: 8 descendants cleared2024: 9 descendants cleared2025: 11 descendants cleared2023: 8 descendants cleared2026: 13 descendants clearedK974093 · Foundation Porous Coated Hemispherical Shell · Encore Orthopedics, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 20 descendants3 generations forward: 16 descendants4 generations forward: 24 descendants5 generations forward: 22 descendants6 generations forward: 10 descendants7 generations forward: 5 descendants8 generations forward: 3 descendants K974093 · Foundation Porous Coated Hemispherical Shell · Encore Orthopedics, Inc. · 19980+5
  1. Root · 1 generation backK974093 Foundation Porous Coated Hemispherical ShellEncore Orthopedics, Inc. · 1998
  2. This deviceK072888 Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked…Encore Medical L.P. · 2008
  3. Descendant · cites it directly · 74 of its ownK112069 RSP Glenoid Baseplate Porous CoatedEncore Medical L.P. · 2011 · Recalled
  4. Descendant · 2 generations on · 55 of its ownK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
  5. Descendant · 3 generations on · 34 of its ownK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
  6. Descendant · cites it directly · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
  7. Descendant · 2 generations on · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12013: 12014: 62015: 32016: 32017: 62018: 42019: 72020: 82021: 102022: 122023: 82024: 92025: 112026: 13
2010high 13 (2026) · low 0 (2012)2026

Most influential descendants

Showing 5 of 103 · See all
  • K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P. · 2011 · cites it directly74descendants
  • K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014 · 2 generations on55descendants
  • K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · 3 generations on34descendants
  • K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · cites it directly25descendants
  • K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · 2 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K974093Foundation Porous Coated Hemispherical ShellEncore Orthopedics, Inc.1998—
0 (this device)K072888Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked…Encore Medical L.P.2008—
+1K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P.20111
+2K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.2014—
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.20166
+1K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.2010—
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201310
201460
201530
201630
201760
201840
201970
202080
2021100
2022120
202380
202490
2025110
2026130
FIG. 1 — Lineage of K072888, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K974093Foundation Porous Coated Hemispherical Shell
Summary page 1
…W/ kNunbtCiarCodl~ CatedProus Foundaiong (MPT Act a1 974093, K974095, and K(973 119 - Founatio® Poous cetaularJanuary oate (FMTM)…
Encore Orthopedics, Inc.1998—
*K974095Foundation Porous Coated Flared Rim Shell
Summary page 1
…kNunbtCiarCodl~ CatedProus Foundaiong (MPT Act a1 974093, K974095, and K(973 119 - Founatio® Poous cetaularJanuary oate (FMTM)…
Encore Orthopedics, Inc.1998—
*K973119Foundation Porous Acetabular SystemEncore Orthopedics, Inc.1998—

Also cleared against K974093: 6 other devices →

What descends from it? (103)

See all 103

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P.201174
K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025
K190057DJO Acetabular SystemEncore Medical L.P.20192

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K112069 (Encore Medical L.P., 2011) has gone furthest, with 74 descendants of its own.
  • 6 other devices also cite its predicate K974093.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

Joint replacement is indicated for patients suffering from disability due to:

* noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;

* rheumatoid arthritis;

* correction of functional deformity;

* femoral fracture

This device may also be indicated in the salvage of previously failed surgical attempts.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072888: Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and Flared).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072888

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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