510(k) · Cleared
ClearedUnited Orthopedic Knee Patient Specific Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enhatch, Inc. · OOG Knee Arthroplasty Implantation System
Cleared on Dec 20, 2023 as substantially equivalent to K171269 (Orthosoft Inc (D/B/A Zimmer Cas), 2017) and 2 other predicates after a 267-day review. Its family tree reaches back 8 generations to 1993.
- Decided
- Dec 20, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- OOG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K924630 (1993). 16 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- 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 backK121640 Zimmer Patient Specific Instruments SystemMaterialise NV · 2012 · Recalled
- 2 generations backK131409 Cas Psi Knee SystemOrthosoft, Inc. · 2013 · Recalled
- 1 generation backK171269 X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2017
- This deviceK230850 United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc. · 2023
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 | K121640 | Zimmer Patient Specific Instruments System | Materialise NV | 2012 | 1 |
| −2 | K131409 | Cas Psi Knee System | Orthosoft, Inc. | 2013 | 1 |
| −1 | K171269 | X-PSI Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2017 | — |
| 0 (this device) | K230850 | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 OOG? 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 OOG device
- #1 K203421 Triathlon AS-1score 6.3 · 18 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K171269 | X-PSI Knee SystemSummary page 5…atory Class: Class II Product Code: OOG, PBF, LLZ 4. PREDICATE DEVICES Primary predicate device: • X-PSI Knee System, Orthosoft (K171269) Secondary predicate devices: • VSP Orthopedics System, 3D Systems (K211244) • United Orthopedic Corporation U2 Tota… | 2017 |
| * | K211244 | VSP® Orthopedics SystemSummary page 5…PREDICATE DEVICES Primary predicate device: • X-PSI Knee System, Orthosoft (K171269) Secondary predicate devices: • VSP Orthopedics System, 3D Systems (K211244) • United Orthopedic Corporation U2 Total Knee System (K051640) K230850… | 2021 |
| * | K051640 | U2 Total Knee SystemSummary page 5…ystem, Orthosoft (K171269) Secondary predicate devices: • VSP Orthopedics System, 3D Systems (K211244) • United Orthopedic Corporation U2 Total Knee System (K051640) K230850 page 2 of 8 5. DESCRIPTION OF THE DEVICE The United Orthopedic… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 5 of the 16 ancestors have a recall of any class.
How does its category compare?
All OOG devicesOOG Knee Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OOG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OOG
Too few OOG 510(k)s in any year since 2007 to give a median.
Recalls per year · OOG
3in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOG
34in 2025
MAUDE reports naming product code OOG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 3 | 30 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 72 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The United Orthopedic Knee Patient Specific Instrumentation is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems. It is comprised of surgical planning software (Intelligent Surgery Knee CT Segmentation Engine/Knee X-ray Segmentation Engine, and Implant Recognition Engine) intended to preoperatively plan the surgical placement of the United Orthopedics Knee implants on the basis of…
Read the full statement (178 words)
The United Orthopedic Knee Patient Specific Instrumentation is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems. It is comprised of surgical planning software (Intelligent Surgery Knee CT Segmentation Engine/Knee X-ray Segmentation Engine, and Implant Recognition Engine) intended to preoperatively plan the surgical placement of the United Orthopedics Knee implants on the basis of provided patient radiological images and 3D reconstructions of bones with identifiable anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The United Orthopedic Knee Patient Specific Instrumentation is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia.
The instruments are intended for use with the U2 Total Knee System when the clinical evaluation complies with its evaluation complies with its cleared indications for use. The instruments are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230850 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230850: United Orthopedic Knee Patient Specific Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230850
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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