510(k) · Cleared
ClearedArcos Trochanter Button
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 Apr 19, 2013 as substantially equivalent to K090757 (Biomet, Inc., 2009) after a 99-day review. Its family tree reaches back 6 generations to 1994. 3 later devices descend from it.
- Decided
- Apr 19, 2013
- Review
- 99 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921308 (1994). 25 ancestors in all, the oldest K921274 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 5 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 4 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 3 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 2 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 1 generation backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- This deviceK130063 Arcos Trochanter ButtonBiomet, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK190100 USTAR II SystemUnited Orthopedic Corporation · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK252303 Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK243656 U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025
Most influential descendants
Showing 3 of 3 · See all- K190100USTAR II SystemUnited Orthopedic Corporation · 2019 · cites it directly2descendants
- K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025 · 2 generations on0descendants
- K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −5 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −4 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −3 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −2 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −1 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| 0 (this device) | K130063 | Arcos Trochanter Button | Biomet, Inc. | 2013 | — |
| +1 | K190100 | USTAR II System | United Orthopedic Corporation | 2019 | 5 |
| +2 | K252303 | Stem Extension Line (USTAR II System) | United Orthopedic Corporation | 2025 | — |
| +2 | K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K090757 | Biomet Modular Femoral Revision SystemSummary page 2…d (888.3360) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The predicate device is the Biomet Modular Femoral Revision Modular System (Arcos), K090757. Device Description: The Arcos Trochanteric Button is being added to the Arcos Modular Femoral Revision System, K090757, to expa… | 2009 |
| † | K031693 | Mallory/Head Modular Calcar with and Without HA | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190100 | USTAR II System | 2019 | 2 |
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 19 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 12 of the 25 ancestors have a recall of any class.
- Of its descendants, K190100 (United Orthopedic Corporation, 2019) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K090757.
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. 2013, 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. Noninflammatory 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.
The Arcos Modular Femoral Revision System Trochanteric Button hip components are single-use implants, intended for uncemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130063 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130063: Arcos Trochanter Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130063
Report an extraction error
Are you the manufacturer?
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