510(k) · Cleared
ClearedSMS Femoral Stem
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 Nov 28, 2018 as substantially equivalent to K071723 (Zimmer GmbH, 2008) and 1 other predicate after a 154-day review. Its family tree reaches back 8 generations to 1994. 4 later devices descend from it.
- Decided
- Nov 28, 2018
- Review
- 154 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K921308 (1994). 68 ancestors in all, the oldest K845025 (1985). 4 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 7 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 6 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 5 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 4 generations backK103479 Novel Tapered Hip StemStryker Corp. · 2011
- 3 generations backK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- 2 generations backK123604 Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · Recalled
- 1 generation backK170845 MiniMAXMedacta International S.A. · 2017 · Recalled
- This deviceK181693 SMS Femoral StemMedacta International S.A. · 2018
- Descendant · cites it directly · 3 of its ownK201673 SMS Cementless StemMedacta International S.A. · 2020
- Descendant · cites it directly · 1 of its ownK203041 SMS Cementless StemMedacta International S.A. · 2020
- Descendant · cites it directly · 0 of its ownK250450 Coated hip implantsMedacta International S.A. · 2025
- Descendant · 2 generations on · 0 of its ownK231925 MINIMA S SystemLima Corporate S.P.A. · 2023
Most influential descendants
Showing 4 of 4 · See all- K201673SMS Cementless StemMedacta International S.A. · 2020 · cites it directly3descendants
- K203041SMS Cementless StemMedacta International S.A. · 2020 · cites it directly1descendant
- K250450Coated hip implantsMedacta International S.A. · 2025 · cites it directly0descendants
- K231925MINIMA S SystemLima Corporate S.P.A. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −7 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −6 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −5 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −4 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| −3 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| −2 | K123604 | Abg Iii Monolithic Hip Stem | Howmedica Osteonics Corp. | 2013 | 1 |
| −1 | K170845 | MiniMAX | Medacta International S.A. | 2017 | 1 |
| 0 (this device) | K181693 | SMS Femoral Stem | Medacta International S.A. | 2018 | — |
| +1 | K201673 | SMS Cementless Stem | Medacta International S.A. | 2020 | — |
| +1 | K203041 | SMS Cementless Stem | Medacta International S.A. | 2020 | — |
| +1 | K250450 | Coated hip implants | Medacta International S.A. | 2025 | — |
| +2 | K231925 | MINIMA S System | Lima Corporate S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K071723 | Zimmer Porolock Mis StemSummary page 4…CFR 888.3360 Device Classification I II1. Predicate Device Substantial equivalence is claimed to the following devices: e Primary Predicate: Zimmer Porolock MIS Stem, K071723, Zimmer GmbH; and e Additional Predicate: MiniIMAX, K170845, Medacta International SA. IV. Device Description The SMS femoral s… | 2008 |
| * | K170845 | MiniMAXSummary page 4…Substantial equivalence is claimed to the following devices: e Primary Predicate: Zimmer Porolock MIS Stem, K071723, Zimmer GmbH; and e Additional Predicate: MiniIMAX, K170845, Medacta International SA. IV. Device Description The SMS femoral stem is a cementless bone preserving short stem designed for… | 2017 |
What descends from it? (4)
3 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 24 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 26 of the 68 ancestors have a recall of any class.
- Of its descendants, K201673 (Medacta International S.A., 2020) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K071723.
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. 2018, 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 SMS is designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery.
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181693: SMS Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181693
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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