510(k) · Cleared
Recalled · Class II · 2019Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V Alloy, CP Grade Titanium)
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 Feb 26, 2009 as substantially equivalent to K063303 (Zimmer, Inc., 2006) after a 78-day review. Its family tree reaches back 3 generations to 2000. 12 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 26, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000684 (2000). 12 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 2 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
- 1 generation backK063303 Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc. · 2006 · Recalled
- This deviceK083654 Zimmer Universal Locking System 2.7 MM Locking Plates and Screws (…Zimmer, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
- Descendant · 2 generations on · 4 of its ownK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- Descendant · 3 generations on · 3 of its ownK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
- 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 · 2 of its ownK120360 Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011 · cites it directly8descendants
- K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017 · 2 generations on4descendants
- K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · 3 generations on3descendants
- K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd. · 2018 · cites it directly2descendants
- K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −2 | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | Zimmer, Inc. | 2006 | 5 |
| −1 | K063303 | Universal Locking System, 2.7MM Plates & Screws | Zimmer, Inc. | 2006 | 4 |
| 0 (this device) | K083654 | Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium… | Zimmer, Inc. | 2009 | — |
| +1 | K102845 | Mahe Fixation Plate and Screw System | Mahe Medical GmbH | 2011 | — |
| +2 | K172943 | Flex-Thread Fibula Pin System | Intrafuse, LLC | 2017 | — |
| +3 | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021 | 2 |
| +1 | K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws… | Meril Healthcare Pvt., Ltd. | 2018 | — |
| +2 | K120360 | Ortho Solutions Trauma Plates for Osteosysnthesis | Ortho Solutions Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K063303 | Universal Locking System, 2.7MM Plates & ScrewsSummary page 1…Zimmer Universal Locking System, 2.7mmn Plates and Screws, manufactured by Zimmer, Inc., K063303, cleared November 22, 2006 Device Description: The Zimmer Universal Locking System is a plate… | 2006 |
What descends from it? (12)
See all 122 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0312-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 11, 2013 | Class II | Z-1041-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K102845 (Mahe Medical GmbH, 2011) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K063303.
How does its category compare?
All HRS devicesHRS Plate, 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 · 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?
The Universal Locking System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:
o Comminuted fractures
o Supracondylar fractures
o Extra-articular fractures
o Fractures in osteopenic bone
o Nonunions
o Malunions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083654: Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V Alloy, CP Grade Titanium).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083654
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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