510(k) · Cleared

Cleared

UNIKO PointCloud™ Knee Instruments

K240327510(k) TraditionalCleared Jun 27, 2024146-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unik Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jun 27, 2024 as substantially equivalent to K122053 (Stryker Corp., 2012) and 1 other predicate after a 146-day review. Its family tree reaches back 8 generations to 1993. 2 of the 16 devices in its family, counting itself, have a Class I recall.

Decided: Jun 27, 2024
Review: 146 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 8 generations to K924630 (1993). 15 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet. 2 of the 16 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
7 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
6 generations backK033849 Simplant SystemMaterialise NV · 2004
5 generations backK073449 SurgicaseMaterialise NV · 2008
4 generations backK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
3 generations backK113829 Zimmer Patient Specific Instrument System Zimmer Patient Specific…Materialise NV · 2012
2 generations backK140027 Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV · 2014
1 generation backK193312 UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc. · 2020
This deviceK240327 UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc. · 2024

Class I recalls in this family

K122053 Shapematch Cutting Guidedirect predicate · 2012
K110533 Stryker Patient Specific Cutting Guide2 generations back · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K924630	Surgicad (TM) View (TM)	Surgicad Corp.	1993	—
−7	K970617	CT-Modeller System	Materialise NV	1997	—
−6	K033849	Simplant System	Materialise NV	2004	—
−5	K073449	Surgicase	Materialise NV	2008	—
−4	K102795	Signature Planner; Signature Guides	Materialise NV	2011	4
−3	K113829	Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments…	Materialise NV	2012	—
−2	K140027	Zimmer Patient Specific Instruments/ System/Planner	Materialise NV	2014	—
−1	K193312	UNIKO PointCloud™ Knee Instruments	Unik Orthopedics, Inc.	2020	—
0 (this device)	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

FIG. 1 — Lineage of K240327, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K122053	Shapematch Cutting Guide Summary page 4 …submission, the UNIKO PointCloud™ Knee Instruments, is substantially equivalent to the Primary Predicate, Stryker ShapeMatch Cutting Guides cleared by FDA through 510(k) K122053, and the Secondary Predicate, UNIKO PointCloud™ Knee Instruments which were cleared by FDA through 510(k) K193312. The subject de…	Stryker Corp.	2012	Class I
*	K193312	UNIKO PointCloud™ Knee Instruments Summary page 4 …ShapeMatch Cutting Guides cleared by FDA through 510(k) K122053, and the Secondary Predicate, UNIKO PointCloud™ Knee Instruments which were cleared by FDA through 510(k) K193312. The subject device has the same intended use, indications for use, design, material, operational principles, and performance as…	Unik Orthopedics, Inc.	2020	—

Also cleared against K122053: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.

K122053Shapematch Cutting GuideStryker Corp. · 2012 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
K110533Stryker Patient Specific Cutting GuideStryker Corp. · 2011 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
5 of the 15 ancestors have a recall of any class; 2 have a Class I recall.
1 other device also cites its predicate K122053.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	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 intraoperatively 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 MRI scans. The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO…

Read the full statement (115 words)

The UNIKO PointCloud™ Knee Instruments are intended to be used as a surgical instrument to assist in the positioning

of Total Knee Replacement components intraoperatively 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 MRI scans.

The UNIKO PointCloud™ Knee Instruments are compatible with the femoral and tibial components of the DJO Surgical

EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System. The Indications for Use of the DJO

Surgical EMPWR 3D Knee System and the Maxx Orthopedics Freedom Total Knee System remain the same as those

cleared in the manufacturer’s clearances for the implant system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K240327 · printed Nov 6, 2026

Cite this page

510(k) Report. “K240327: UNIKO PointCloud™ Knee Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240327

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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