510(k) · Cleared
ClearedMedallion Modular Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Dec 21, 2004 as substantially equivalent to K000788 (Apex Surgical, LLC, 2000) and 3 other predicates after a 166-day review. Its family tree reaches back 2 generations to 1991. 1 of the 10 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 21, 2004
- Review
- 166 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K913231 (1991). 8 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK913231 S-Rom (TM) Total Lhip System W/Ceramic HeadJoint Medical Products Corp. · 1991
- 1 generation backK000788 Apex Modular Hip StemApex Surgical, LLC · 2000
- This deviceK041850 Medallion Modular Hip SystemBiomet Manufacturing, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK130149 U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation · 2013
Class I recalls in this family
- K003016 Pro-Femur Rdirect predicate · 2000
Most influential descendants
Showing 1 of 1 · See all- K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913231 | S-Rom (TM) Total Lhip System W/Ceramic Head | Joint Medical Products Corp. | 1991 | — |
| −1 | K000788 | Apex Modular Hip Stem | Apex Surgical, LLC | 2000 | — |
| 0 (this device) | K041850 | Medallion Modular Hip System | Biomet Manufacturing, Inc. | 2004 | — |
| +1 | K130149 | U2 Hip System, Expanded Indications for Use | United Orthopedic Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 1 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K000788 | Apex Modular Hip StemSummary page 1…orous, uncemented (888.3558) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * Modular Hip Stem (Apex Surgical, LLC; K000788) * PRO-FEMUR Hip System (Wright Medical Technology, lnc; K012091, K00301 6) * Reach Femoral Component (Bi… | 2000 |
| * | K012091 | Pro-FemurSummary page 1…vices To Which Substantial Equivalence Is Claimed: * Modular Hip Stem (Apex Surgical, LLC; K000788) * PRO-FEMUR Hip System (Wright Medical Technology, lnc; K012091, K00301 6) * Reach Femoral Component (Biomet, Inc; K000760) Device Description: The Medallion Modular Hi… | 2001 |
| * | K003016 | Pro-Femur RSummary page 1…tantial Equivalence Is Claimed: * Modular Hip Stem (Apex Surgical, LLC; K000788) * PRO-FEMUR Hip System (Wright Medical Technology, lnc; K012091, K00301 6) * Reach Femoral Component (Biomet, Inc; K000760) Device Description: The Medallion Modular Hip System is a comple… | 2000 |
| * | K000760 | Reach Femoral ComponentSummary page 1…(Apex Surgical, LLC; K000788) * PRO-FEMUR Hip System (Wright Medical Technology, lnc; K012091, K00301 6) * Reach Femoral Component (Biomet, Inc; K000760) Device Description: The Medallion Modular Hip System is a complete system of femoral stem implants. The implants… | 2000 |
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 |
|---|---|---|---|
| K130149 | U2 Hip System, Expanded Indications for Use | 2013 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K003016Pro-Femur RWrightmedicaltechnologyinc · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K130149 (United Orthopedic Corporation, 2013) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K000788.
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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041850: Medallion Modular 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/K041850
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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