510(k) Report

510(k) · Cleared

Cleared

Orthoglide Lateral Knee Implant and Instruments

K073233510(k) TraditionalCleared Jan 28, 200874-day reviewClass II21 CFR 888.3590

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

Advanced Bio-Surfaces, Inc. · HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

Cleared on Jan 28, 2008 as substantially equivalent to K003269 (Sulzer Orthopedics, Inc., 2001) and 2 other predicates after a 74-day review. Its family tree reaches back 3 generations to 1992.

Decided
Jan 28, 2008
Review
74 days
Class
Class II
Product code
HSH
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K911802 (1992). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2002: 1 other ancestor1997: 1 other ancestor1993: 1 other ancestorK911802 · Pmi (Patient Matched Implants) Hip Femoral Comp · Biomet, Inc. · 1992K033242 · Knee Interpositional Mini-Repair System (Kimrs) · Imaging Therapeutics, Inc. · 2003K053094 · Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056 · Advanced Bio-Surfaces, Inc. · 200619901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors K053094 · Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056 · Advanced Bio-Surfaces, Inc. · 2006K033242 · Knee Interpositional Mini-Repair System (Kimrs) · Imaging Therapeutics, Inc. · 2003K911802 · Pmi (Patient Matched Implants) Hip Femoral Comp · Biomet, Inc. · 19920
  1. Root · 3 generations backK911802 Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc. · 1992
  2. 2 generations backK033242 Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
  3. 1 generation backK053094 Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064…Advanced Bio-Surfaces, Inc. · 2006
  4. This deviceK073233 Orthoglide Lateral Knee Implant and InstrumentsAdvanced Bio-Surfaces, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K911802Pmi (Patient Matched Implants) Hip Femoral CompBiomet, Inc.1992—
−2K033242Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc.2003—
−1K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065…Advanced Bio-Surfaces, Inc.2006—
0 (this device)K073233Orthoglide Lateral Knee Implant and InstrumentsAdvanced Bio-Surfaces, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199710
200110
200210
FIG. 1 — Lineage of K073233, 1992–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K003269Unicondylar Interpositional Spacer
Summary page 1
…r use, 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) Advanced Bio Surfaces, Inc.…
Sulzer Orthopedics, Inc.2001—
*K033242Knee Interpositional Mini-Repair System (Kimrs)
Summary page 1
…. These predicate devices are: Sulzer Orthopedics, Inc. Unicondylar Interpositional Spacer (K003269) ITI, Knee Interpositional Mini-Repair system (KIMRS) (K033242) Advanced Bio Surfaces, Inc. Confidential OrthoGlide Lateral 5 10(k) Premarket N…
Imaging Therapeutics, Inc.2003—
*K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062…
Summary page 2
…3 5909 Baker Road, Suite 550 · Minnetonka, MN 55345 * Phone: (952) 912-5400 * Fax: (952) 912-5410 ABS OrthoGlide® Medial Knee Implant (K053094) Device Description: The OrthoGlide Lateral Knee Implant is placed in the lateral compartment of the knee between the tibi…
Advanced Bio-Surfaces, Inc.2006—

Also cleared against K003269: 2 other devices →

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 16 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • None of the 7 ancestors has a recall.
  • 2 other devices also cite its predicate K003269.

How does its category compare?

All HSH devices

HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · HSH

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

2007: 6482008: 8792009: 1,1152010: 5432011: 222012: 792013: 372014: 162015: 182017: 32018: 32022: 1
2007high 1,115 (2009) · low 0 (2016)2025

MAUDE reports naming product code HSH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—0648
20081—0879
20090—01,115
20100—0543
20110—022
20120—079
20130—037
20140—016
20150—018
20160—00
20170—03
20180—03
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The OrthoGlide Lateral 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 lateral compartment of the knee (grade II-IV chondromalacia) with no more than minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the medial and patellofemoral compartments in patients with osteoarthritis.

Indications for use as stated in the FDA summary.

Also cleared against K003269

2 other devices cite the same predicate.

  • K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056Advanced Bio-Surfaces, Inc. · 2006
  • K033242Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003

More from Advanced Bio-Surfaces, Inc.

2 FDA decisions under this applicant name. See the company

  • K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056Advanced Bio-Surfaces, Inc. · 2006

Recent decisions in HSH

The HSH category page

  • K053094Orthoglide Medical Knee Implant and Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056Advanced Bio-Surfaces, Inc. · 2006
  • K033242Knee Interpositional Mini-Repair System (Kimrs)Imaging Therapeutics, Inc. · 2003
  • K022779Oti Unicondular Interpositional SpacerOsteoimplant Technology, Inc. · 2002
  • K003269Unicondylar Interpositional SpacerSulzer Orthopedics, Inc. · 2001

https://510kreport.com/device/K073233 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073233: Orthoglide Lateral Knee Implant and Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073233

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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