510(k) · Cleared
ClearedZimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HRS Plate, Fixation, Bone
Cleared on Aug 14, 2014 as substantially equivalent to K112885 (Zimmer, Inc., 2011) and 3 other predicates after a 167-day review. Its family tree reaches back 4 generations to 2000. 14 later devices descend from it.
- Decided
- Aug 14, 2014
- Review
- 167 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K000684 (2000). 13 ancestors in all, the oldest K874669 (1987). 14 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 3 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
- 2 generations backK063303 Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc. · 2006 · Recalled
- 1 generation backK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
- This deviceK140508 Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc. · 2014
- Descendant · cites it directly · 12 of its ownK143066 Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions…Zimmer, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK142836 Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK151407 RECON systemNormed Medizin-Technik GmbH · 2015
- Descendant · cites it directly · 4 of its ownK143331 Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK171320 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION…Meril Healthcare Pvt., Ltd. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K143066Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Zimmer, Inc. · 2014 · cites it directly12descendants
- K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc. · 2014 · cites it directly5descendants
- K151407RECON systemNormed Medizin-Technik GmbH · 2015 · 2 generations on4descendants
- K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc. · 2015 · cites it directly4descendants
- K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd. · 2018 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −3 | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | Zimmer, Inc. | 2006 | 5 |
| −2 | K063303 | Universal Locking System, 2.7MM Plates & Screws | Zimmer, Inc. | 2006 | 4 |
| −1 | K112885 | Zimmer Plates and Screws System Screws Only | Zimmer, Inc. | 2011 | 15 |
| 0 (this device) | K140508 | Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws | Zimmer, Inc. | 2014 | — |
| +1 | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions… | Zimmer, Inc. | 2014 | — |
| +1 | K142836 | Zimmer Plates and Screws (ZPS), Forte Screws | Zimmer, Inc. | 2014 | — |
| +2 | K151407 | RECON system | Normed Medizin-Technik GmbH | 2015 | — |
| +1 | K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS | Zimmer, Inc. | 2015 | — |
| +2 | K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws… | Meril Healthcare Pvt., Ltd. | 2018 | — |
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 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K112885 | Zimmer Plates and Screws System Screws OnlySummary page 4…opedics/87, Product codes HRS, HWC, HTN Predicate Devices: Sterile Zimmer Plates and Screws System (ZPS) – Screws only (K112885), TMP Microplating System (K921458), Zimmer Universal Locking System 3.5mm Locking Plates… | 2011 |
| * | K921458 | TMP Microplating SystemSummary page 4…HTN Predicate Devices: Sterile Zimmer Plates and Screws System (ZPS) – Screws only (K112885), TMP Microplating System (K921458), Zimmer Universal Locking System 3.5mm Locking Plates and Sc… | 1992 |
| * | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 ScrewsSummary page 4…, TMP Microplating System (K921458), Zimmer Universal Locking System 3.5mm Locking Plates and Screws (K060710) and Zimmer Universal Locking System 2.7mm Locking Plates and Screws (K063303). Purpose and De… | 2006 |
| * | K063303 | Universal Locking System, 2.7MM Plates & ScrewsSummary page 4…king Plates and Screws (K060710) and Zimmer Universal Locking System 2.7mm Locking Plates and Screws (K063303). Purpose and Device Description: The Zimmer Plates and Screws System (ZPS) is a non- lockin… | 2006 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile… | 2014 | 12 |
| K142836 | Zimmer Plates and Screws (ZPS), Forte Screws | 2014 | 5 |
| K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS | 2015 | 4 |
| K150121 | Zimmer Periarticular Plating System | 2015 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 6 of the 13 ancestors have a recall of any class.
- Of its descendants, K143066 (Zimmer, Inc., 2014) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K112885.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular 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 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/K140508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140508: Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140508
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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