510(k) · Cleared
ClearedMsa Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Manufacturing Technology · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Mar 1, 2011 as substantially equivalent to K071916 (Aesculap Implant Systems, Inc., 2008) and 6 other predicates after a 211-day review. Its family tree reaches back 11 generations to 1994. 1 of the 123 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Mar 1, 2011
- Review
- 211 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 11 generations to K941847 (1994). 120 ancestors in all, the oldest K810258 (1981). 3 later devices descend from it, 2 citing it directly. 1 of the 123 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations between
- 3 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 2 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- This deviceK102172 Msa Hip SystemGlobal Manufacturing Technology · 2011
- Descendant · cites it directly · 1 of its ownK143184 Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK201047 Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK113107 Msa Hip SystemGlobal Manufacturing Technology · 2011
Show all 11 generations
- Root · 11 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 9 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 8 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 7 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 6 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 5 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 4 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 3 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 2 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 1 generation backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- This deviceK102172 Msa Hip SystemGlobal Manufacturing Technology · 2011
Class I recalls in this family
- K091423 Profemur Hip System Modular Necksdirect predicate · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −10 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −9 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −8 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −7 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −6 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −5 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −4 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −3 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −2 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −1 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| 0 (this device) | K102172 | Msa Hip System | Global Manufacturing Technology | 2011 | — |
| +1 | K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | 2015 | — |
| +2 | K201047 | Fusion Taper System | Signature Orthopaedics Pty, Ltd. | 2021 | — |
| +1 | K113107 | Msa Hip System | Global Manufacturing Technology | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 15 | 0 |
| 1995 | 12 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 4 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K071916 | Metha Hip SystemSummary page 2…equivalence of the MSA Hip System to the following predicate devices: Aesculap. Implant System's Metha Short Stem Hip System (K071916 and K080584); Zimmer's Mayo Conservative Hip Prosthesis (K030733 and K943230);… | 2008 |
| * | K080584 | Metha Short Stem Hip SystemSummary page 2…of the MSA Hip System to the following predicate devices: Aesculap. Implant System's Metha Short Stem Hip System (K071916 and K080584); Zimmer's Mayo Conservative Hip Prosthesis (K030733 and K943230); Wright… | 2008 |
| * | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 SeriesSummary page 2…ces: Aesculap. Implant System's Metha Short Stem Hip System (K071916 and K080584); Zimmer's Mayo Conservative Hip Prosthesis (K030733 and K943230); Wright Medical Technology's PROFEMUR Hip System (K08109… | 2003 |
| * | K943230 | Mayo Hip ProsthesisSummary page 2…Metha Short Stem Hip System (K071916 and K080584); Zimmer's Mayo Conservative Hip Prosthesis (K030733 and K943230); Wright Medical Technology's PROFEMUR Hip System (K081090 and K091423); and… | 1997 |
| * | K081090 | Profemur LX 5/8 Coated Hip StemSummary page 2…er's Mayo Conservative Hip Prosthesis (K030733 and K943230); Wright Medical Technology's PROFEMUR Hip System (K081090 and K091423); and OMNI life science, Inc.'s Apex ARCTM Hip System (K090845).… | 2008 |
| * | K091423 | Profemur Hip System Modular NecksSummary page 2…nservative Hip Prosthesis (K030733 and K943230); Wright Medical Technology's PROFEMUR Hip System (K081090 and K091423); and OMNI life science, Inc.'s Apex ARCTM Hip System (K090845).… | 2009 |
| * | K090845 | Apex Arc Hip StemSummary page 2…ology's PROFEMUR Hip System (K081090 and K091423); and OMNI life science, Inc.'s Apex ARCTM Hip System (K090845). The MSA Hip Stem shares the same indications for use for which the predicate syste… | 2010 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 34 of the 119 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K143184 (Signature Orthopaedics Pty, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K071916.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The MSA Hip System is indicated for cementless use and is intended to replace a hip joint.
The device is intended for:
* skeletally mature individuals undergoing primary surgery for total hip replacement
* patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the fenmoral head and nonunion of previous fracture of the femur.
* patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis
* patients Suffering from disability due to previous fusion
* patients with acute femoral neck fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102172: Msa 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/K102172
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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