510(k) · Cleared
ClearedAmis K Long
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 Apr 12, 2022 as substantially equivalent to K192827 (Medacta International S.A., 2020) and 3 other predicates after a 57-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Apr 12, 2022
- Review
- 57 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K935452 (1994). 117 ancestors in all, the oldest K845025 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 7 generations between
- 3 generations backK173794 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A. · 2018
- 2 generations backK181254 Quadra PMedacta International S.A. · 2018
- 1 generation backK192827 Quadra-PMedacta International S.A. · 2020
- This deviceK220405 Amis K LongMedacta International S.A. · 2022
Show all 11 generations
- Root · 11 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 10 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 9 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 8 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 7 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 6 generations backK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
- 5 generations backK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- 4 generations backK161635 AMIStem-H Proximal CoatingMedacta International S.A. · 2017
- 3 generations backK173794 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A. · 2018
- 2 generations backK181254 Quadra PMedacta International S.A. · 2018
- 1 generation backK192827 Quadra-PMedacta International S.A. · 2020
- This deviceK220405 Amis K LongMedacta International S.A. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −10 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −9 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −8 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −7 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K042992 | Corail Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2005 | 1 |
| −5 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| −4 | K161635 | AMIStem-H Proximal Coating | Medacta International S.A. | 2017 | — |
| −3 | 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 | — |
| −1 | K192827 | Quadra-P | Medacta International S.A. | 2020 | — |
| 0 (this device) | K220405 | Amis K Long | Medacta International S.A. | 2022 | — |
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 | 9 | 0 |
| 1995 | 8 | 0 |
| 1996 | 11 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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.
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? (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 |
|---|---|---|---|
| * | K192827 | Quadra-PSummary page 4…fication II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device: Quadra-P Cemented, K192827, Medacta International SA Additional predicate device: M-Vizion K201471, Medacta International SA Quadra… | 2020 |
| * | K201471 | M-Vizion Femoral Revision System ExtensionSummary page 4…to the following devices: Primary predicate device: Quadra-P Cemented, K192827, Medacta International SA Additional predicate device: M-Vizion K201471, Medacta International SA Quadra C, K083558, Medacta International SA Arcos, K100469, Biomet === Page 5 ==… | 2021 |
| * | K083558 | Medacta Total Hip Prosthesis System - Quadra CSummary page 4… Quadra-P Cemented, K192827, Medacta International SA Additional predicate device: M-Vizion K201471, Medacta International SA Quadra C, K083558, Medacta International SA Arcos, K100469, Biomet… | 2009 |
| * | K100469 | Arcos Interlocking Distal StemsSummary page 4…national SA Additional predicate device: M-Vizion K201471, Medacta International SA Quadra C, K083558, Medacta International SA Arcos, K100469, Biomet K220405 Page 2/4… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 34 of the 117 ancestors have a recall of any class.
- 5 other devices also cite its predicate K192827.
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. 2022, 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 AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Total hip replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthrosis, 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…
Read the full statement (131 words)
The hip prosthesis AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Total hip replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthrosis, 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, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty.
Partial hip arthroplasty is indicated in the following cases:
• Acute traumatic fracture of the femoral head or neck
• Non-union of femoral neck fracture
• Avascular necrosis of the femoral head.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220405: Amis K Long.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220405
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