510(k) · Cleared
ClearedNavipro Knee Software Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinamed, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Mar 11, 2004 as substantially equivalent to K003347 (Kinamed, Inc., 2001) and 1 other predicate after a 111-day review. Its family tree reaches back 2 generations to 2001. 40 later devices descend from it.
- Decided
- Mar 11, 2004
- Review
- 111 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003347 (2001). 40 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003347 OrthopilotKinamed, Inc. · 2001
- 1 generation backK020764 NaviproKinamed, Inc. · 2002
- This deviceK033668 Navipro Knee Software ModuleKinamed, Inc. · 2004
- Descendant · cites it directly · 39 of its ownK050897 Navipro Shoulder Software ModuleKinamed, Inc. · 2005
- Descendant · 2 generations on · 38 of its ownK130126 Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013
- Descendant · 3 generations on · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · 4 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- Descendant · 5 generations on · 23 of its ownK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K050897Navipro Shoulder Software ModuleKinamed, Inc. · 2005 · cites it directly39descendants
- K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc. · 2013 · 2 generations on38descendants
- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · 3 generations on31descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 4 generations on25descendants
- K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017 · 5 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003347 | Orthopilot | Kinamed, Inc. | 2001 | — |
| −1 | K020764 | Navipro | Kinamed, Inc. | 2002 | — |
| 0 (this device) | K033668 | Navipro Knee Software Module | Kinamed, Inc. | 2004 | — |
| +1 | K050897 | Navipro Shoulder Software Module | Kinamed, Inc. | 2005 | — |
| +2 | K130126 | Signature Personalized Patient Care System - Glenoid Guide System | Biomet, Inc. | 2013 | — |
| +3 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +4 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| +5 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K003347 | OrthopilotSummary page 1…NaviPro' Knee Software Module ® Inc. Substantial equivalence claimed to: 1. OrthoPilot (K003347) filed by Kinamed 2. NaviPro (K020764) TM… | 2001 |
| * | K020764 | NaviproSummary page 1…® Inc. Substantial equivalence claimed to: 1. OrthoPilot (K003347) filed by Kinamed 2. NaviPro (K020764) TM filed by Kinamed, In… | 2002 |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050897 | Navipro Shoulder Software Module | 2005 | 39 |
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 3 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K050897 (Kinamed, Inc., 2005) has gone furthest, with 39 descendants of its own.
- 8 other devices also cite its predicate K003347.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The NaviPro TM Knee Software Module is an extension of the NaviProTM Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033668 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033668: Navipro Knee Software Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033668
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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