510(k) · Cleared
ClearedAMIStem-H Proximal Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 31, 2017 as substantially equivalent to K093944 (Medacta International S.A., 2010) and 1 other predicate after a 290-day review. Its family tree reaches back 7 generations to 1994. 10 later devices descend from it.
- Decided
- Mar 31, 2017
- Review
- 290 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K935452 (1994). 68 ancestors in all, the oldest K845025 (1985). 10 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 6 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 5 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 4 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 2 generations backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- 1 generation backK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- This deviceK161635 AMIStem-H Proximal CoatingMedacta International S.A. · 2017
- Descendant · cites it directly · 9 of its ownK173794 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A. · 2018
- Descendant · 2 generations on · 7 of its ownK181254 Quadra PMedacta International S.A. · 2018
- Descendant · 3 generations on · 6 of its ownK192827 Quadra-PMedacta International S.A. · 2020
- Descendant · 3 generations on · 1 of its ownK202730 Quadra-PMedacta International S.A. · 2020
- Descendant · 4 generations on · 1 of its ownK203041 SMS Cementless StemMedacta International S.A. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A. · 2018 · cites it directly9descendants
- K181254Quadra PMedacta International S.A. · 2018 · 2 generations on7descendants
- K192827Quadra-PMedacta International S.A. · 2020 · 3 generations on6descendants
- K202730Quadra-PMedacta International S.A. · 2020 · 3 generations on1descendant
- K203041SMS Cementless StemMedacta International S.A. · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −6 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −5 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −4 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| −1 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| 0 (this device) | K161635 | AMIStem-H Proximal Coating | Medacta International S.A. | 2017 | — |
| +1 | K173794 | AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared | Medacta International S.A. | 2018 | — |
| +2 | K181254 | Quadra P | Medacta International S.A. | 2018 | — |
| +3 | K192827 | Quadra-P | Medacta International S.A. | 2020 | — |
| +3 | K202730 | Quadra-P | Medacta International S.A. | 2020 | — |
| +4 | K203041 | SMS Cementless Stem | Medacta International S.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 8 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K093944 | Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SSummary page 4…quivalence is claimed to the following devices: Primary Predicate: x Medacta Total Hip Prosthesis – AMIStem H, Quadra S and Quadra H femoral stems, K093944, Medacta International SA Additional Predicates: x Avenir® Müller Stem, K123392, Zimmer GmbH Reference Device:… | 2010 |
| * | K123392 | Avenir Muller StemSummary page 4…al Hip Prosthesis – AMIStem H, Quadra S and Quadra H femoral stems, K093944, Medacta International SA Additional Predicates: x Avenir® Müller Stem, K123392, Zimmer GmbH Reference Device: x AMIStem and Quadra – Line Extension, K121011, Medacta International SA === Page 5 ==… | 2013 |
| † | K121011 | Amistem and Quadra - Line Extension | 2012 |
What descends from it? (10)
2 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 23 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 16 of the 68 ancestors have a recall of any class.
- Of its descendants, K173794 (Medacta International S.A., 2018) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K093944.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The hip prosthesis AMIStem-H, AMIStem-H Collared, AMIStem-H Proximal Coating are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid…
Read the full statement (108 words)
The hip prosthesis AMIStem-H, AMIStem-H Collared, AMIStem-H Proximal Coating are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia
• Avascular necrosis of the femoral head
• Acute traumatic fracture of the femoral head or neck
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161635: AMIStem-H Proximal Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161635
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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