510(k) · Cleared
ClearedEcho Bi-Metric Microplasty Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Dec 18, 2014 as substantially equivalent to K070274 (Biomet Manufacturing Corp, 2007) and 2 other predicates after a 59-day review. Its family tree reaches back 7 generations to 1985. 1 later device descends from it.
- Decided
- Dec 18, 2014
- Review
- 59 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K850055 (1985). 73 ancestors in all, the oldest K845025 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 6 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 5 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 4 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 3 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 2 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- 1 generation backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- This deviceK143009 Echo Bi-Metric Microplasty Hip SystemBiomet, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK150503 Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −6 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −5 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −4 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −3 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −2 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| −1 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| 0 (this device) | K143009 | Echo Bi-Metric Microplasty Hip System | Biomet, Inc. | 2014 | — |
| +1 | K150503 | Echo Bi-Metric Microplasty Line Extension | Biomet, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 13 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K070274 | Echo BI-Metric Press-Fit StemsSummary page 5…LPH, LZO, KWZ, JDI, KWL, LWJ, KWY, OQG, OQH, OQI, PBI Legally marketed device(s) Predicate Devices: to which equivalence is K070274 Echo Bi-Metric Press Fit Stem (Biomet) claimed K110400 Taperloc® Complete Microplasty System (Biomet)… | 2007 |
| * | K110400 | Taperloc Complete Microplasty StemSummary page 5…, OQH, OQI, PBI Legally marketed device(s) Predicate Devices: to which equivalence is K070274 Echo Bi-Metric Press Fit Stem (Biomet) claimed K110400 Taperloc® Complete Microplasty System (Biomet) K050251 Balance Hip System Microplasty Stem (Biomet)… | 2011 |
| * | K050251 | Balance Hip SystemSummary page 5…e is K070274 Echo Bi-Metric Press Fit Stem (Biomet) claimed K110400 Taperloc® Complete Microplasty System (Biomet) K050251 Balance Hip System Microplasty Stem (Biomet) Reference Devices: K09075… | 2005 |
| † | K090757 | Biomet Modular Femoral Revision System | 2009 |
| † | K133184 | Ardis Interbody System | 2014 |
| † | K130610 | Sirius Femoral Stem | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150503 | Echo Bi-Metric Microplasty Line Extension | 2015 | 0 |
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 29 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 15 of the 73 ancestors have a recall of any class.
- Of its descendants, K150503 (Biomet, Inc., 2015) has gone furthest, with 0 descendants of its own.
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. 2014, 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?
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty
Porous coated components are intended for uncemented, biological fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143009: Echo Bi-Metric Microplasty 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/K143009
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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