510(k) · Cleared
ClearedMedacta Bone Screws - Evolis and Versafit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · HWC Screw, Fixation, Bone
Cleared on Jun 1, 2009 as substantially equivalent to K011719 (Plus Orthopedics, 2001) and 1 other predicate after a 48-day review. Its family tree reaches back 8 generations to 1994. 23 later devices descend from it.
- Decided
- Jun 1, 2009
- Review
- 48 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K941847 (1994). 88 ancestors in all, the oldest K840643 (1984). 23 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 6 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 5 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 4 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 3 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 2 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 1 generation backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- This deviceK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- Descendant · cites it directly · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 2 generations on · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
- Descendant · 2 generations on · 11 of its ownK132879 Mpact ExtensionMedacta International · 2014
- Descendant · 2 generations on · 4 of its ownK183582 MPACT ExtensionMedacta International S.A. · 2019
- Descendant · cites it directly · 4 of its ownK103352 Versafitcup CC TrioMedacta International · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K103721Mpact Acetabular SystemMedacta International · 2011 · cites it directly21descendants
- K122641Mpact ExtensionMedacta International · 2012 · 2 generations on14descendants
- K132879Mpact ExtensionMedacta International · 2014 · 2 generations on11descendants
- K183582MPACT ExtensionMedacta International S.A. · 2019 · 2 generations on4descendants
- K103352Versafitcup CC TrioMedacta International · 2011 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −7 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −6 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −5 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −3 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −2 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −1 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| 0 (this device) | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| +1 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +2 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| +2 | K132879 | Mpact Extension | Medacta International | 2014 | — |
| +2 | K183582 | MPACT Extension | Medacta International S.A. | 2019 | — |
| +1 | K103352 | Versafitcup CC Trio | Medacta International | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K011719 | Plus Cancellous Bone ScrewsSummary page 1…tion, Bone 21 CFR 888.3560 Class 1I Device Product Code: JWH Predicate Devices: K01 1719 Plus Cancellous Bone Screws K081023 Evolis Total Knee System Product Description: The Medacta Bone S… | 2001 |
| * | K081023 | Evolis Total Knee SystemSummary page 1…Class 1I Device Product Code: JWH Predicate Devices: K01 1719 Plus Cancellous Bone Screws K081023 Evolis Total Knee System Product Description: The Medacta Bone Screws are intended to provide additional bone fixation of the t… | 2008 |
What descends from it? (23)
See all 232 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 15 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 31 of the 87 ancestors have a recall of any class.
- Of its descendants, K103721 (Medacta International, 2011) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K011719.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Medacta Bone Screws are intended to provide additional bone fixation of the
tibial components of the Evolis Total Knee System.
The Evolis Total Knee System is designed for cemented use in total knee
arthroplasty, if there is evidence of sufficient sound bone to seat and support the
components.
This knee replacement system is indicated in the following cases:
Severely painful and/or disabled joint as a result of arthritis, traumatic
arthritis, rheumatoid arthritis or polyarthritis
avascular necrosis of femoral condyle
post traumatic loss of joint configuration.
primary implantation failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091069: Medacta Bone Screws - Evolis and Versafit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091069
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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