510(k) · Cleared
ClearedZimmer Hip Computer Assisted Solutions Electromagnetic and Imageless Instrumentation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Nov 8, 2006 as substantially equivalent to K033223 (Zimmer, Inc., 2004) after a 98-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Nov 8, 2006
- Review
- 98 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022126 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK022126 Catheter Introducer for the Stealthstation SystemMedtronic Surgical Navigation Technologies · 2003
- 1 generation backK033223 Zimmer Ortho Guidance Systems- Hip InstrumentsZimmer, Inc. · 2004
- This deviceK062228 Zimmer Hip Computer Assisted Solutions Electromagnetic and Imageless…Zimmer, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022126 | Catheter Introducer for the Stealthstation System | Medtronic Surgical Navigation Technologies | 2003 | — |
| −1 | K033223 | Zimmer Ortho Guidance Systems- Hip Instruments | Zimmer, Inc. | 2004 | — |
| 0 (this device) | K062228 | Zimmer Hip Computer Assisted Solutions Electromagnetic and Imageless… | Zimmer, Inc. | 2006 | — |
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? (1)
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 |
|---|---|---|---|
| * | K033223 | Zimmer Ortho Guidance Systems- Hip InstrumentsSummary page 1…ce: 21 CFR § 882.4560 Predicate Devices: Zimmer Ortho Guidance Systems - IHip Instruments, K033223, cleared February 18, 2004. Device Description: This submission is for:… | 2004 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K033223.
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?
Zimmer Hip Computer Assisted Solutions Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any hip orthopedic medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to:
Total or Hemi-Hip Arthroplasty (Primary and Revision)
Minimally Invasive Hip Orthopedic Procedures
Tumor Resection and Bone/Joint Reconstruction
Stabilization of Repair of Pelvic/Femoral Fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062228: Zimmer Hip Computer Assisted Solutions Electromagnetic and Imageless Instrumentation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062228
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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