510(k) · Cleared
Recalled · Class II · 2019CLS Brevius Stem with Kinectiv Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Oct 7, 2011 as substantially equivalent to K042249 (Zimmer Austin, Inc., 2004) and 3 other predicates after a 196-day review. Its family tree reaches back 8 generations to 1985. 1 of the 22 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Oct 7, 2011
- Review
- 196 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K850055 (1985). 21 ancestors in all. No later device cites it as a predicate yet. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 7 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 6 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 5 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 4 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 3 generations backK042337 Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 2004
- 2 generations backK063251 Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc. · 2007 · Recalled
- 1 generation backK071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System…Zimmer, Inc. · 2007 · Recalled (Class I)
- This deviceK110836 CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH · 2011
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…direct predicate · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −7 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −6 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −5 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −4 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −3 | K042337 | Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 2004 | — |
| −2 | K063251 | Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology | Zimmer, Inc. | 2007 | 4 |
| −1 | K071856 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S)… | Zimmer, Inc. | 2007 | Class I |
| 0 (this device) | K110836 | CLS Brevius Stem with Kinectiv Technology | Zimmer GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K042249 | CLS Spotorno StemSummary page 2…semi-constrained cemented prosthesis Predicate Device: CLS'm Spotornor m Femoral Stem, manufactured by Zimmer Austin, Inc., K042249, cleared September 15, 2004 Zinimer® MIL Taper Hip Prosthesis with Kinecti… | 2004 |
| * | K081007 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemSummary page 2…Zinimer® MIL Taper Hip Prosthesis with Kinectivm Technology System, manufactured by Zimmer Inc., K08 1007, cleared May 6, 2008 Zimmer® M/L Taper Hip Prosthesis with KineeiivM Techn… | 2008 |
| * | K071856 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Summary page 2…Zimmer® M/L Taper Hip Prosthesis with KineeiivM Technology System, manufactured by Zimmer Inc., K071856, cleared July 30, 2007 Ziminer®MIL Taper Hip Prosthesis with Modular Neck… | 2007 |
| * | K063251 | Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologySummary page 2…Ziminer®MIL Taper Hip Prosthesis with Modular Neck Technology, manufactured by Zimmer Inc. K063251, cleared January 24, 2007 Device Description: The CLS Brevius Stem with Kinectiv Technology is… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0319-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 10 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K042249.
How does its category compare?
All KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KWA
4in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
MAUDE reports naming product code KWA, 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 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Total hip replacement for patients with:
a Noninflamniatory degenerative joint disease (NLDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Femoral neck fractures.
Failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed hip arthroplasty.
Hemi-hip replacement for patients with:
Femoral neck fractures.
This femoral stem is for cementless use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110836 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110836: CLS Brevius Stem with Kinectiv Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110836
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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