510(k) · Cleared
Recalled · Class II · 2019Zimmer Porolock Mis Stem
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 Mar 7, 2008 as substantially equivalent to K032726 (Zimmer, Inc., 2003) and 2 other predicates after a 256-day review. Its family tree reaches back 5 generations to 1985. 73 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 7, 2008
- Review
- 256 days
- Class
- Class III
- Product code
- KWA
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K850055 (1985). 44 ancestors in all, the oldest K845025 (1985). 73 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 4 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 3 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 2 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 1 generation backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- This deviceK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008
- Descendant · cites it directly · 41 of its ownK123392 Avenir Muller StemZimmer GmbH · 2013 · Recalled
- Descendant · cites it directly · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- Descendant · cites it directly · 19 of its ownK130899 Biolox Delta Ceramic Femoral HeadsZimmer GmbH · 2013
- Descendant · 2 generations on · 14 of its ownK120030 Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012
- Descendant · 2 generations on · 11 of its ownK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K123392Avenir Muller StemZimmer GmbH · 2013 · cites it directly41descendants
- K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · cites it directly34descendants
- K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH · 2013 · cites it directly19descendants
- K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012 · 2 generations on14descendants
- K121034Ioi Total HipIconacy Orthopedic Implants, LLC · 2012 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −4 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −3 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −2 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −1 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| 0 (this device) | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | — |
| +1 | K123392 | Avenir Muller Stem | Zimmer GmbH | 2013 | 4 |
| +1 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| +1 | K130899 | Biolox Delta Ceramic Femoral Heads | Zimmer GmbH | 2013 | — |
| +2 | K120030 | Taperloc Complete Size 4MM and XR 123 | Biomet Manufacturing Corp | 2012 | — |
| +2 | K121034 | Ioi Total Hip | Iconacy Orthopedic Implants, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 9 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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 KWA? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 SeriesSummary page 2…112 Predicate Device: Zinmmer M/L Taper Flip Prosthesis, manulhctured by Zimmer, Inc., K032726, cleared October 22, 2003. Duromn Acetabular Component and Ae'fcasul… | 2003 |
| * | K053536 | Durom Acetabular Component and Metasul LDH Large Diameter HeadsSummary page 2…03. Duromn Acetabular Component and Ae'fcasul LDHIM Large Diameter Heads, manufactured by Zimmer GmbH, K053536, cleared March 16, 2006. Alloc/assicR ZweylmuellerR SL/SLL Femoral Stein, manufactur… | 2006 |
| * | K030373 | Alloclassic Zweymueller SL/SLL Femoral StemSummary page 2…Zimmer GmbH, K053536, cleared March 16, 2006. Alloc/assicR ZweylmuellerR SL/SLL Femoral Stein, manufactured by Zimmer GnmbH, K030373, cleared March 6, 2003. Device Description: The Zimmer Porolock MIS Stem is a modular… | 2003 |
What descends from it? (73)
See all 738 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123392 | Avenir Muller Stem | 2013 | 41 |
| K110400 | Taperloc Complete Microplasty Stem | 2011 | 34 |
| K130899 | Biolox Delta Ceramic Femoral Heads | 2013 | 19 |
| K181693 | SMS Femoral Stem | 2018 | 4 |
| K201673 | SMS Cementless Stem | 2020 | 3 |
| K192236 | Fitmore Hip Stem | 2019 | 1 |
| K140547 | Excera Fitrite Total Hip Arthroplasty System | 2015 | 1 |
| K170072 | Fitmore® Hip Stem | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0320-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Sep 4, 2012 | Class II | Z-0220-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 11 of the 44 ancestors have a recall of any class.
- Of its descendants, K123392 (Zimmer GmbH, 2013) has gone furthest, with 41 descendants of its own.
- 6 other devices also cite its predicate K032726.
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. 2008, 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?
This femoral stem is for total or hemi-hip arthoplasty and is indicated for the following conditions: Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory degenerative joint disease (J10), e.g., rheumatoid arthritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed 1ip arthroplasty. Total hip replacements…
Read the full statement (126 words)
This femoral stem is for total or hemi-hip arthoplasty and is indicated for the following conditions: Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory degenerative joint disease (J10), e.g., rheumatoid arthritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed 1ip arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the 4tuality of their lives,
This stem is for uncemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071723 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071723: Zimmer Porolock Mis Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071723
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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