510(k) Report

510(k) · Cleared

Cleared

The Progressive Orthopaedic Total Hip System

K151424510(k) TraditionalCleared Jul 27, 2016426-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

The Progressive Orthopaedic Company, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jul 27, 2016 as substantially equivalent to K143314 (The Progressive Orthopaedic Company, LLC, 2015) and 1 other predicate after a 426-day review. Its family tree reaches back 10 generations to 1981. 1 later device descends from it.

Decided
Jul 27, 2016
Review
426 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
2

Its longest line of descent runs back 10 generations to K810258 (1981). 75 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor2014: 1 other ancestor2000: 9 other ancestors2011: 1 other ancestor2010: 2 other ancestors2009: 3 other ancestors2004: 3 other ancestors1999: 2 other ancestors1994: 7 other ancestors2008: 1 other ancestor2007: 3 other ancestors2002: 4 other ancestors2001: 3 other ancestors1998: 2 other ancestors1996: 3 other ancestors1995: 7 other ancestors2006: 1 other ancestor2005: 3 other ancestors2003: 2 other ancestors1993: 2 other ancestors1992: 3 other ancestors1991: 1 other ancestor1997: 1 other ancestor2019: 1 descendant clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010K120370 · Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners · Zimmer, Inc. · 2012K140701 · Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug · Novosource, Inc. · 201419801990200020102020
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 6 generations between
  3. 3 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  4. 2 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
  5. 1 generation backK140701 Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 2014
  6. This deviceK151424 The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2016
  7. Descendant · cites it directly · 0 of its ownK192450 Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC · 2019
Show all 10 generations
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 4 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. 3 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  9. 2 generations backK120370 Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc. · 2012
  10. 1 generation backK140701 Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc. · 2014
  11. This deviceK151424 The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−9K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−8K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−7K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−6K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−5K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−4K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
−3K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010—
−2K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.2012—
−1K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.2014—
0 (this device)K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC2016—
+1K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199230
199320
199470
199570
199630
199710
199820
199920
200090
200130
200240
200320
200430
200530
200610
200730
200810
200930
201020
201110
201410
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K151424, 1981–2019Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K143314Progressive Orthopaedic Total Hip System
Summary page 4
…theOrthopedicspanel/87asaClassIIdevice.  DeviceProductCode: LPH,LZO PredicateDevices: ProgressiveOrthopaedicTotalHipSystem(K143314)  NovoSourceNovoHipTotalHipSystem(K140701)  DeviceDescription: Thepresent510kThePro…
The Progressive Orthopaedic Company, LLC2015—
*K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole Plug
Summary page 4
…LPH,LZO PredicateDevices: ProgressiveOrthopaedicTotalHipSystem(K143314)  NovoSourceNovoHipTotalHipSystem(K140701)  DeviceDescription: Thepresent510kTheProgressiveOrthopaedicadditionalscrewsizesandapicalholeplugare components…
Novosource, Inc.2014—

Also cleared against K143314: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190

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 35 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
  • 20 of the 75 ancestors have a recall of any class.
  • Of its descendants, K192450 (Precision Casting Solution, LLC, 2019) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K143314.

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. 2016, 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?

The Progressive Orthopaedic Total Hip System implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and acetabular portions of the hip that are severely disabled and/or very painful as a result of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

• Rheumatoid arthritis or traumatic arthritis

• Correction of functional deformity

• Non-union femoral neck fracture

• Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K151424: The Progressive Orthopaedic Total Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151424

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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