510(k) · Cleared
ClearedPlus Cancellous Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · HWC Screw, Fixation, Bone
Cleared on Jul 2, 2001 as substantially equivalent to K993874 (Plus Orthopedics, 2000) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1990. 63 later devices descend from it.
- Decided
- Jul 2, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K903362 (1990). 10 ancestors in all. 63 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK903362 Osteolock (TM) Acetabular CupHowmedica Corp. · 1990
- 2 generations backK971854 Osteolock Acetabular Shell SystemHowmedica Corp. · 1997
- 1 generation backK993874 Bofor Revision CoupPlus Orthopedics · 2000
- This deviceK011719 Plus Cancellous Bone ScrewsPlus Orthopedics · 2001
- Descendant · cites it directly · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 2 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · cites it directly · 23 of its ownK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- Descendant · 2 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on32descendants
- K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009 · cites it directly23descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 2 generations on21descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903362 | Osteolock (TM) Acetabular Cup | Howmedica Corp. | 1990 | — |
| −2 | K971854 | Osteolock Acetabular Shell System | Howmedica Corp. | 1997 | — |
| −1 | K993874 | Bofor Revision Coup | Plus Orthopedics | 2000 | — |
| 0 (this device) | K011719 | Plus Cancellous Bone Screws | Plus Orthopedics | 2001 | — |
| +1 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +2 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +1 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| +2 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +3 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K993874 | Bofor Revision CoupSummary page 1…ws are presently available, non-sterile, as part of complete instrument and implant sets for the following predicate devices manufactured by PLUS: BOFOR® Revision Cup - K993874 — S/E/ 6/5/00 EPF®-PLUS Acetabular Cup - K994146 — S/E 12/11/00 These identical cancellous bone screws are now available, steri… | 2000 |
| * | K994146 | Epf-Plus Cementless Press-Fit Acetabular CupSummary page 1…f complete instrument and implant sets for the following predicate devices manufactured by PLUS: BOFOR® Revision Cup - K993874 — S/E/ 6/5/00 EPF®-PLUS Acetabular Cup - K994146 — S/E 12/11/00 These identical cancellous bone screws are now available, sterile, packaged individually in triple peel pouches (… | 2000 |
What descends from it? (63)
See all 634 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 11 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K123055 (Smith & Nephew, Inc., 2013) has gone furthest, with 33 descendants of its own.
- 1 other device also cites its predicate K993874.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PLUS Cancellous Bone Screws are intended as a bone fixation device for a variety of surgical applications, such as fixation of press-fit acetabular cups in total hip arthroplasty or acetabular revisions, tibial components in total knee arthroplasty of knee revisions, and fixation of small and long bone fractures.
WARNING: These cancellous bone screws are not intended for spinal fixation.
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/K011719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011719: Plus Cancellous Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011719
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026