510(k) · Cleared
ClearedZimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HWC Screw, Fixation, Bone
Cleared on Nov 24, 2015 as substantially equivalent to K143066 (Zimmer, Inc., 2014) and 1 other predicate after a 56-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Nov 24, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K000684 (2000). 19 ancestors in all, the oldest K874669 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
- 5 generations backK063303 Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc. · 2006 · Recalled
- 4 generations backK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
- 3 generations backK140508 Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc. · 2014
- 2 generations backK142836 Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc. · 2014
- 1 generation backK143331 Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc. · 2015
- This deviceK152841 Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | Zimmer, Inc. | 2006 | 5 |
| −5 | K063303 | Universal Locking System, 2.7MM Plates & Screws | Zimmer, Inc. | 2006 | 4 |
| −4 | K112885 | Zimmer Plates and Screws System Screws Only | Zimmer, Inc. | 2011 | 15 |
| −3 | K140508 | Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws | Zimmer, Inc. | 2014 | — |
| −2 | K142836 | Zimmer Plates and Screws (ZPS), Forte Screws | Zimmer, Inc. | 2014 | — |
| −1 | K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS | Zimmer, Inc. | 2015 | — |
| 0 (this device) | K152841 | Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws | Zimmer, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Summary page 4…: Orthopedics/87 Predicate Device(s): Zimmer® Plates and Screws, Non-sterile 2.7mm cortical screws cleared under K143066 on November 28, 2014. Zimmer Plates and Screws System (ZPS) – Non-sterile… | 2014 |
| * | K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSSummary page 4…er K143066 on November 28, 2014. Zimmer Plates and Screws System (ZPS) – Non-sterile ZPS cleared under K143331 on March 04, 2015 Reference Predicate Only: Universal Locking… | 2015 |
| † | K063303 | Universal Locking System, 2.7MM Plates & Screws | 2006 |
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 15 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 7 of the 19 ancestors have a recall of any class.
- 5 other devices also cite its predicate K143066.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as: • comminuted fractures • supracondylar fractures • extra-articular fractures • fractures in osteopenic bone • nonunions…
Read the full statement (111 words)
ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, Contourable Dual Compression Plates, Cloverleaf and Spoon Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• fractures in osteopenic bone
• nonunions
• malunions
Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152841 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152841: Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152841
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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