510(k) · Cleared
ClearedWafer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 24, 2004 as substantially equivalent to K973812 (Arthrex, Inc., 1998) and 1 other predicate after a 254-day review. Its family tree reaches back 1 generation to 1998. 23 later devices descend from it.
- Decided
- Jun 24, 2004
- Review
- 254 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973812 (1998). 2 ancestors in all. 23 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK973812 Arthrex Puddu Osteotomy SystemArthrex, Inc. · 1998
- This deviceK033303 Wafer SystemSpine Wave, Inc. · 2004
- Descendant · cites it directly · 12 of its ownK053336 Staxx FX SystemSpine Wave, Inc. · 2006
- Descendant · 2 generations on · 11 of its ownK063606 Modification to Staxx FX SystemSpine Wave, Inc. · 2007
- Descendant · 3 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
- Descendant · cites it directly · 8 of its ownK052670 Staxx XD SystemSpine Wave, Inc. · 2006
- Descendant · 2 generations on · 6 of its ownK090315 Staxx XD SystemSpine Wave, Inc. · 2009
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K053336Staxx FX SystemSpine Wave, Inc. · 2006 · cites it directly12descendants
- K063606Modification to Staxx FX SystemSpine Wave, Inc. · 2007 · 2 generations on11descendants
- K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 3 generations on9descendants
- K052670Staxx XD SystemSpine Wave, Inc. · 2006 · cites it directly8descendants
- K090315Staxx XD SystemSpine Wave, Inc. · 2009 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973812 | Arthrex Puddu Osteotomy System | Arthrex, Inc. | 1998 | — |
| 0 (this device) | K033303 | Wafer System | Spine Wave, Inc. | 2004 | — |
| +1 | K053336 | Staxx FX System | Spine Wave, Inc. | 2006 | — |
| +2 | K063606 | Modification to Staxx FX System | Spine Wave, Inc. | 2007 | — |
| +3 | K132817 | Kiva VCF Treatment System | Benvenue Medical, Inc. | 2014 | — |
| +1 | K052670 | Staxx XD System | Spine Wave, Inc. | 2006 | — |
| +2 | K090315 | Staxx XD System | Spine Wave, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K973812 | Arthrex Puddu Osteotomy SystemSummary page 1…ion. V. Substantial Equivalence The Wafer System was demonstrated to be substantially equivalent to the Arthrex Opening Wedge Osteotomy System (K973812) and the Synthes Spiked Washer (KOI 1583). In addition, mechanical testing demonstrated that The Wafer System m… | 1998 |
| * | K011583 | Spiked Washer | 2002 |
What descends from it? (23)
See all 233 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?
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 Wafer System, in conjunction with commercially available supplemental fixation, is intended for use in proximal tibial opening wedge osteotomies as a means to restore anatomical alignment and relative position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033303: Wafer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033303
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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