510(k) · Cleared
ClearedTaperloc Complete Size 4MM and XR 123
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Aug 17, 2012 as substantially equivalent to K101086 (Biomet, Inc., 2010) and 2 other predicates after a 226-day review. Its family tree reaches back 7 generations to 1985. 14 later devices descend from it.
- Decided
- Aug 17, 2012
- Review
- 226 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K850055 (1985). 51 ancestors in all, the oldest K845025 (1985). 14 later devices descend from it, 4 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 deviceK120030 Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012
- Descendant · cites it directly · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- Descendant · 2 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- Descendant · 2 generations on · 3 of its ownK210678 implaFit® hip stemsImplantcast GmbH · 2022
- Descendant · 2 generations on · 1 of its ownK240834 EcoFit® short stem cementless cpTiImplantcast GmbH · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · cites it directly9descendants
- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 2 generations on5descendants
- K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 2 generations on4descendants
- K210678implaFit® hip stemsImplantcast GmbH · 2022 · 2 generations on3descendants
- K240834EcoFit® short stem cementless cpTiImplantcast GmbH · 2024 · 2 generations on1descendant
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) | K120030 | Taperloc Complete Size 4MM and XR 123 | Biomet Manufacturing Corp | 2012 | — |
| +1 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +2 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +2 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
| +2 | K210678 | implaFit® hip stems | Implantcast GmbH | 2022 | — |
| +2 | K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K101086 | Taperloc CompleteSummary page 2…vice Description: Taperloce Complete Size 4mm Stems The Taperloc® Complete Size 4mm stems will combine the design features of the Taperloc® Complete full- length stems (K101086 and K103755) and the shortened design of the new Taperloc® Complete Microplasty, K110400. This submission is extending the implan… | 2010 |
| * | K103755 | Taperloc Complete, Size 5 and 6Summary page 2…Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Taperloc® Complete Stems-Biomet-(K<101086) Taperloc® Complete, Sizes 5mm and 6mm-Biomet-(K103755) Taperloc® Complete Microplasty Stems-Biomet-(K110400) Device Description: Taperloce Complete Size 4mm Stems The Taperloc®… | 2011 |
| * | K110400 | Taperloc Complete Microplasty StemSummary page 2…e Is Claimed: Taperloc® Complete Stems-Biomet-(K<101086) Taperloc® Complete, Sizes 5mm and 6mm-Biomet-(K103755) Taperloc® Complete Microplasty Stems-Biomet-(K110400) Device Description: Taperloce Complete Size 4mm Stems The Taperloc® Complete Size 4mm stems will combine the design features… | 2011 |
What descends from it? (14)
See all 144 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)
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 27 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 12 of the 51 ancestors have a recall of any class.
- Of its descendants, K163577 (Implantcast GmbH, 2017) has gone furthest, with 9 descendants of its own.
- 8 other devices also cite its predicate K101086.
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. 2012, 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 by other techniques.
5. Revision procedures where other treatment or devices have failed.
Porous coated components are intended for uncemented biological fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120030: Taperloc Complete Size 4MM and XR 123.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120030
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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