510(k) · Cleared
ClearedTsy Shoulder Plate Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopedic Sciences, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 24, 2004 as substantially equivalent to K022139 (Orthopedic Sciences, Inc., 2002) after an 85-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Jun 24, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K850886 (1985). 42 ancestors in all, the oldest K770128 (1977). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK850886 Compression Hip Screw SystemPfizer, Inc. · 1985 · Recalled
- 3 generations backK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996 · Recalled
- 2 generations backK970258 Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of…Ferguson Medical · 1997
- 1 generation backK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
- This deviceK040850 Tsy Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK063033 Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K063033Modification to Titanium Shoulder Plate ImplantOrthopedic Sciences, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850886 | Compression Hip Screw System | Pfizer, Inc. | 1985 | 1 |
| −3 | K955306 | Omega+ Compression Screw System | Howmedica Corp. | 1996 | 1 |
| −2 | K970258 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable… | Ferguson Medical | 1997 | — |
| −1 | K022139 | Hip Tool Implant | Orthopedic Sciences, Inc. | 2002 | — |
| 0 (this device) | K040850 | Tsy Shoulder Plate Implant | Orthopedic Sciences, Inc. | 2004 | — |
| +1 | K063033 | Modification to Titanium Shoulder Plate Implant | Orthopedic Sciences, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1979 | 3 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K022139 | Hip Tool ImplantSummary page 1…e uedicate device for this modification is the Hip Tool" Implant, a component of the Hip Tool Bone Graft Stabilization System, cleared by FDA on September 23, 2002 under K022 139. INTENDED USE The TSY'M Shoulder Plate Implant is intended to stabilize a bone graft within the hunmeral head and neck to assi… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063033 | Modification to Titanium Shoulder Plate Implant | 2006 | 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 19 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 6 of the 42 ancestors have a recall of any class.
- Of its descendants, K063033 (Orthopedic Sciences, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K022139.
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 TSYTM Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040850: Tsy Shoulder Plate Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040850
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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