510(k) · Cleared
ClearedSmith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HRS Plate, Fixation, Bone
Cleared on Dec 9, 1999 after an 83-day review. The FDA summary names its predicate without a number. 1 of the 729 devices in its family, counting itself, has a Class I recall. 728 later devices descend from it.
- Decided
- Dec 9, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
728 later devices descend from it, 36 citing it directly. 1 of the 729 devices in this family, counting this one, has a Class I recall.
- This deviceK993106 Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and…Smith & Nephew, Inc. · 1999
- Descendant · cites it directly · 690 of its ownK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · cites it directly · 531 of its ownK060736 Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · cites it directly · 501 of its ownK062216 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · Recalled
- Descendant · cites it directly · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
Showing 5 of 728 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 728 · See all- K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc. · 2003 · cites it directly690descendants
- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · 2 generations on584descendants
- K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · cites it directly531descendants
- K062216Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2006 · cites it directly501descendants
- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · cites it directly495descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) | Smith & Nephew, Inc. | 1999 | — |
| +1 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| +2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +1 | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated Screws | Smith & Nephew, Inc. | 2006 | 1 |
| +1 | K062216 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2006 | 1 |
| +1 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 11 | 0 |
| 2010 | 13 | 0 |
| 2011 | 15 | 0 |
| 2012 | 21 | 0 |
| 2013 | 26 | 0 |
| 2014 | 37 | 0 |
| 2015 | 41 | 0 |
| 2016 | 32 | 0 |
| 2017 | 52 | 0 |
| 2018 | 30 | 0 |
| 2019 | 38 | 0 |
| 2020 | 41 | 0 |
| 2021 | 47 | 1 |
| 2022 | 43 | 0 |
| 2023 | 53 | 0 |
| 2024 | 67 | 0 |
| 2025 | 59 | 0 |
| 2026 | 73 | 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.
1 device in this family has a Class I recall. 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? (7)
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 |
|---|---|---|---|
| * | — | Richards Bone Plates and Bone Screws (Smith & Nephew [f/k/a Richards Medical Company]) Named without a submission number | |
| * | — | Osteo Bone Plates and Bone Screws (Smith & Nephew) Named without a submission number | |
| * | — | Titanium Plates (Synthes) Named without a submission number | |
| * | — | Basic Screw Set (Synthes) Named without a submission number | |
| * | — | ECT Plates and Screws (Zimmer) Named without a submission number | |
| * | — | TiMAX™ Large Fragment System (DePuy) Named without a submission number | |
| * | — | TiMAX™ Bone Screws (DePuy) Named without a submission number |
What descends from it? (728)
See all 72836 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | 2003 | 690 |
| K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated Screws | 2006 | 531 |
| K062216 | Peri-Loc Periarticular Locked Plating System | 2006 | 501 |
| K071563 | Peri-Loc Periarticular Locked Plating System | 2007 | 495 |
| K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications | 2008 | 186 |
| K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | 2008 | 87 |
| K083032 | Peri-Loc Bone Plating and Screw System | 2009 | 77 |
| K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws… | 2011 | 69 |
| K073344 | Orthopediatrics Plating System | 2008 | 66 |
| K081407 | Orthopediatrics Pediplates System | 2008 | 65 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K033669 (Smith & Nephew, Inc., 2003) has gone furthest, with 690 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Smith & Nephew Bone Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole 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/K993106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993106: Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993106
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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