510(k) · Cleared
ClearedUNIKO PointCloud™ Knee Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unik Orthopedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Aug 12, 2020 as substantially equivalent to K140027 (Materialise NV, 2014) and 1 other predicate after a 257-day review. Its family tree reaches back 7 generations to 1993. 2 of the 16 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Aug 12, 2020
- Review
- 257 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K924630 (1993). 14 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK073449 SurgicaseMaterialise NV · 2008
- 3 generations backK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
- 2 generations backK113829 Zimmer Patient Specific Instrument System Zimmer Patient Specific…Materialise NV · 2012
- 1 generation backK140027 Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV · 2014
- This deviceK193312 UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK240327 UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K240327UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K073449 | Surgicase | Materialise NV | 2008 | — |
| −3 | K102795 | Signature Planner; Signature Guides | Materialise NV | 2011 | 4 |
| −2 | K113829 | Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments… | Materialise NV | 2012 | — |
| −1 | K140027 | Zimmer Patient Specific Instruments/ System/Planner | Materialise NV | 2014 | — |
| 0 (this device) | K193312 | UNIKO PointCloud™ Knee Instruments | Unik Orthopedics, Inc. | 2020 | — |
| +1 | K240327 | UNIKO PointCloud™ Knee Instruments | Unik Orthopedics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
2 devices in this family have 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 20.0 · 8 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 |
|---|---|---|---|
| * | K140027 | Zimmer Patient Specific Instruments/ System/PlannerSummary page 4…logy and Performance to the following legally marketed devices in commercial distribution: Zimmer Patient Specific Instrument System 6.0 which was cleared by FDA through K140027 and the Stryker ShapeMatch Cutting Guide cleared through K122053 Device Description: The UNIKO PointCloud™ Knee Instruments use… | 2014 |
| * | K122053 | Shapematch Cutting GuideSummary page 4…commercial distribution: Zimmer Patient Specific Instrument System 6.0 which was cleared by FDA through K140027 and the Stryker ShapeMatch Cutting Guide cleared through K122053 Device Description: The UNIKO PointCloud™ Knee Instruments use the TKA surgical plan that is output from the Vault® System Surgi… | 2012 |
| † | K124051 | The Vault System | 2013 |
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 |
|---|---|---|---|
| K240327 | UNIKO PointCloud™ Knee Instruments | 2024 | 0 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 5 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K240327 (Unik Orthopedics, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K140027.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical EMPWR 3D Knee System. The Indications for Use of the DJO Surgical EMPWR 3D Knee System remain the same as those cleared in the manufacturer’s clearance for the implant system.
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/K193312 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193312: UNIKO PointCloud™ Knee Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193312
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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