510(k) · Cleared
ClearedZimmer Plates and Screws System (ZPS) - Non-sterile ZPS
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 Mar 4, 2015 as substantially equivalent to K140508 (Zimmer, Inc., 2014) and 2 other predicates after a 104-day review. Its family tree reaches back 6 generations to 2000. 4 later devices descend from it.
- Decided
- Mar 4, 2015
- Review
- 104 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K000684 (2000). 18 ancestors in all, the oldest K874669 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
- 4 generations backK063303 Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc. · 2006 · Recalled
- 3 generations backK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
- 2 generations backK140508 Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc. · 2014
- 1 generation backK142836 Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc. · 2014
- This deviceK143331 Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK171320 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION…Meril Healthcare Pvt., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK241599 Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK200701 Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK152841 Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd. · 2018 · cites it directly2descendants
- K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd. · 2025 · 2 generations on0descendants
- K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc. · 2020 · 2 generations on0descendants
- K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | Zimmer, Inc. | 2006 | 5 |
| −4 | K063303 | Universal Locking System, 2.7MM Plates & Screws | Zimmer, Inc. | 2006 | 4 |
| −3 | K112885 | Zimmer Plates and Screws System Screws Only | Zimmer, Inc. | 2011 | 15 |
| −2 | K140508 | Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws | Zimmer, Inc. | 2014 | — |
| −1 | K142836 | Zimmer Plates and Screws (ZPS), Forte Screws | Zimmer, Inc. | 2014 | — |
| 0 (this device) | K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS | Zimmer, Inc. | 2015 | — |
| +1 | K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws… | Meril Healthcare Pvt., Ltd. | 2018 | — |
| +2 | K241599 | Signature Osteosynthesis Plate System | Signature Orthopaedic Pty, Ltd. | 2025 | — |
| +2 | K200701 | Skeletal Dynamics Midshaft Humerus Plating System | Skeletal Dynamics, Inc. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 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? (3)
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 |
|---|---|---|---|
| * | K140508 | Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsSummary page 4…Orthopedics/87 Predicate Device(s): ZPS 2.7mm L-Plate, 3.5mm One Third Tubular Plate, 4.5mm T-Plate and 3.5 T Plate, (K140508, cleared August 14, 2014), ZPS 4.5mm T-Plate (K143066, cleared… | 2014 |
| * | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile… Cleared while this submission was under review Summary page 4…Tubular Plate, 4.5mm T-Plate and 3.5 T Plate, (K140508, cleared August 14, 2014), ZPS 4.5mm T-Plate (K143066, cleared November 28, 2014), and ZPS 3.5/4.5mm Contourable Du… | 2014 |
| * | K142836 | Zimmer Plates and Screws (ZPS), Forte ScrewsSummary page 4…T-Plate (K143066, cleared November 28, 2014), and ZPS 3.5/4.5mm Contourable Dual Compression Plates (K142836, cleared November 12,2014) Purpose and Device Description: The ZPS System is a non-locking,… | 2014 |
What descends from it? (4)
2 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 2 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 18 ancestors have a recall of any class.
- Of its descendants, K171320 (Meril Healthcare Pvt., Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K140508.
How does its category compare?
All HRS devicesHRS Plate, 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 · 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, 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…
Read the full statement (104 words)
ZPS One-Third Tubular Plates, T-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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143331: Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143331
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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