510(k) · Cleared
ClearedBiomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip Applications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · HAW Neurological Stereotaxic Instrument
Cleared on Mar 21, 2006 as substantially equivalent to K033341 (Smith & Nephew, Inc., 2004) and 3 other predicates after a 63-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Mar 21, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K010612 (2001). 14 ancestors in all, the oldest K983831 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 3 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 2 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 1 generation backK052178 Depuy Cas Hip InstrumentationDePuy Orthopaedics, Inc. · 2005
- This deviceK060121 Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments…Biomet Manufacturing Corp · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −3 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −2 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −1 | K052178 | Depuy Cas Hip Instrumentation | DePuy Orthopaedics, Inc. | 2005 | — |
| 0 (this device) | K060121 | Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip… | Biomet Manufacturing Corp | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K033341 | Smith & Nephew Image Guided Surgical Instruments for Hip ApplicationsSummary page 1…nt, Stereotaxic (21 CFR 888.4560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: 1. Smith & Nephew Image-Guided Instruments for Hip Applications (K033341) 2. BrainLAB VectorVision® Hip 3.0 Image Guided Surgery System (K040368) 3. DePuy CAS Hip Instrumentation (K052178) 4. BrainLAB V… | 2004 |
| * | K040368 | Vectorvision Hip 3.0Summary page 1…stantial Equivalence Is Claimed: 1. Smith & Nephew Image-Guided Instruments for Hip Applications (K033341) 2. BrainLAB VectorVision® Hip 3.0 Image Guided Surgery System (K040368) 3. DePuy CAS Hip Instrumentation (K052178) 4. BrainLAB VectorVision® Hip Software on the a platform (K052213) Device Descriptio… | 2004 |
| * | K052178 | Depuy Cas Hip InstrumentationSummary page 1…Nephew Image-Guided Instruments for Hip Applications (K033341) 2. BrainLAB VectorVision® Hip 3.0 Image Guided Surgery System (K040368) 3. DePuy CAS Hip Instrumentation (K052178) 4. BrainLAB VectorVision® Hip Software on the a platform (K052213) Device Description: The Biomet Pre-Calibrated Computer Aided… | 2005 |
| * | K052213 | Navigation SW Hip 3.1 on CISummary page 1…BrainLAB VectorVision® Hip 3.0 Image Guided Surgery System (K040368) 3. DePuy CAS Hip Instrumentation (K052178) 4. BrainLAB VectorVision® Hip Software on the a platform (K052213) Device Description: The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are reus… | 2005 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 2 other devices also cite its predicate K033341.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a…
Read the full statement (125 words)
The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Biomet Pre-Calibrated Computer Aided Surgery (CAS) Navigation Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as long bone can be identified relative to a CT based model or by an individual 3D model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to acetabular cup replacement as part of a partial or total hip arthroplasty (primary or revision).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060121: Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060121
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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