510(k) · Cleared
ClearedOrthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Bio-Surfaces, Inc. · HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Cleared on Feb 6, 2006 as substantially equivalent to K003269 (Sulzer Orthopedics, Inc., 2001) and 1 other predicate after a 95-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Feb 6, 2006
- Review
- 95 days
- Class
- Class II
- Product code
- HSH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911802 (1992). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
- 1 generation backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
- This deviceK053094 Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064…Advanced Bio-Surfaces, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK073233 Orthoglide Lateral Knee Implant and InstrumentsAdvanced Bio-Surfaces, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073233Orthoglide Lateral Knee Implant and InstrumentsAdvanced Bio-Surfaces, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911802 | Pmi (Patient Matched Implants) Hip Femoral Comp | Biomet, Inc. | 1992 | — |
| −1 | K033242 | Knee Interpositional Mini-Repair System (Kimrs) | Imaging Therapeutics, Inc. | 2003 | — |
| 0 (this device) | K053094 | Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065… | Advanced Bio-Surfaces, Inc. | 2006 | — |
| +1 | K073233 | Orthoglide Lateral Knee Implant and Instruments | Advanced Bio-Surfaces, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 HSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K003269 | Unicondylar Interpositional SpacerSummary page 1…materials, technological characteristics and surgical techniques. These predicate devices are: Sulzer Orthopedics, Inc. Unicondylar Interpositional Spacer (K003269) ITI, Knee Interpositional Mini-Repair system (KIMRS) (K033242) 5909 Baker Road Suite 550 I Minnetonka, M… | 2001 |
| * | K033242 | Knee Interpositional Mini-Repair System (Kimrs)Summary page 1…e devices are: Sulzer Orthopedics, Inc. Unicondylar Interpositional Spacer (K003269) ITI, Knee Interpositional Mini-Repair system (KIMRS) (K033242) 5909 Baker Road Suite 550 I Minnetonka, MN 55345 K Phone (952) 912-5400 · Fax (952) 912-5410 U E-Mail info~advbiosurfc… | 2003 |
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 |
|---|---|---|---|
| K073233 | Orthoglide Lateral Knee Implant and Instruments | 2008 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K073233 (Advanced Bio-Surfaces, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K003269.
How does its category compare?
All HSH devicesHSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSH
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · HSH
Too few HSH 510(k)s in any year since 2007 to give a median.
Recalls per year · HSH
No recall names HSH since 2007.
Adverse event reports per year · HSH
1in 2022
MAUDE reports naming product code HSH, 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 | 648 |
| 2008 | 1 | — | 0 | 879 |
| 2009 | 0 | — | 0 | 1,115 |
| 2010 | 0 | — | 0 | 543 |
| 2011 | 0 | — | 0 | 22 |
| 2012 | 0 | — | 0 | 79 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Orthoglide Medial Knee Implant is intended for use in the osteoarthritic knee,
where substantial amounts of cartilage have been lost as a result of the disease.
The device is indicated for uncemented use in the treatment of moderate degeneration of the
medial compartment of the knee (grade II-IV chondromalacia) with no more than minimal
degeneration (grade I-Il chondromalacia, no loss of joint space) in the lateral and
patellofemoral compartments in patients with ostcoarthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053094: Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053094
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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